novolog
Generic: insulin aspart
Labeler: novo nordiskDrug Facts
Product Profile
Brand Name
novolog
Generic Name
insulin aspart
Labeler
novo nordisk
Dosage Form
INJECTION, SOLUTION
Routes
Active Ingredients
insulin aspart 100 [iU]/mL
Manufacturer
Identifiers & Regulatory
Product NDC
0169-6338
Product ID
0169-6338_de82c22d-ea25-44ef-8bcd-c3cda9e84e59
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
BLA
Application Number
BLA020986
Listing Expiration
2026-12-31
Marketing Start
2013-10-31
Pharmacologic Class
Established (EPC)
Chemical Structure
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
01696338
Hyphenated Format
0169-6338
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
novolog (source: ndc)
Generic Name
insulin aspart (source: ndc)
Application Number
BLA020986 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 100 [iU]/mL
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied NOVOLOG (insulin aspart) injection 100 units/mL (U-100) is available as a clear and colorless solution in: One 10 mL multiple-dose vial per carton NDC 0169-7501-11 ReliOn ® brand NDC 0169-2100-11 Five 3 mL single-patient-use FlexPen prefilled pens per carton NDC 0169-6339-10 ReliOn ® brand NDC 0169-2101-25 Five 3 mL single-patient-use PenFill prefilled cartridges* per carton NDC 0169-3303-12 Five 3 mL single-patient-use FlexTouch prefilled pens per carton NDC 0169-6338-10 *NOVOLOG PenFill cartridges are designed for use with compatible insulin delivery devices with NovoFine disposable needles. FlexPen and FlexTouch can be used with NovoFine or NovoTwist disposable needles. The NOVOLOG FlexPen and FlexTouch dial in 1-unit increments. 16.2 Recommended Storage Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused NOVOLOG in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze NOVOLOG and do not use NOVOLOG if it has been frozen. Do not expose NOVOLOG to excessive heat or light. Do not withdraw NOVOLOG into a syringe and store for later use. Always remove and discard the needle after each injection from the NOVOLOG FlexPen or NOVOLOG FlexTouch and store without a needle attached. The storage conditions are summarized in the following table: Table 9. Storage Conditions for vial, PenFill cartridges, NOVOLOG FlexPen, and NOVOLOG FlexTouch NOVOLOG presentation Not in-use (unopened) Room Temperature (up to 30°C [86°F]) Not in-use (unopened) Refrigerated (2°C to 8°C [36°F to 46°F]) In-use (opened) Room Temperature (up to 30°C [86°F]) 10 mL multiple-dose vial 28 days Until expiration date 28 days* (refrigerated/room temperature) 3 mL single-patient-use PenFill cartridges 28 days Until expiration date 28 days (Do not refrigerate) 3 mL single-patient-use FlexPen 28 days Until expiration date 28 days (Do not refrigerate) 3 mL single-patient-use FlexTouch 28 days Until expiration date 28 days (Do not refrigerate) *For insulin pump use, the total in-use time is 19 days, including 7 days pump in-use time. Storage in External Insulin Pump: Change the NOVOLOG in the pump reservoir at least every 7 days or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 37°C (98.6°F). Storage of Diluted NOVOLOG NOVOLOG diluted with Insulin Diluting Medium for NOVOLOG to a concentration equivalent to U-10 or equivalent to U-50 prepared as indicated under Dosage and Administration (2.2) may remain in patient use at temperatures up to 30°C (86°F) for 28 days. Storage of NOVOLOG in Intravenous Infusion Fluids Infusion bags prepared as indicated under Dosage and Administration (2.2) are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion.
- PRINCIPAL DISPLAY PANEL - 10 mL NovoLog Vial NovoLog ® NDC 0169-7501-11 (insulin aspart) injection List 750111 100 units/mL (U-100) For intravenous or subcutaneous use. Rx only Use only with a U-100 syringe. 10 mL multiple-dose vial NovoLog Vial (NN) Carton - 8-0902-31-305-9
- PRINCIPAL DISPLAY PANEL - 10 mL NovoLog ReliOn Vial NovoLog ® (insulin aspart) injection NDC 0169-2100-11 List 210011 100 units/mL (U-100) For intravenous or subcutaneous use. Rx only Use only with a U-100 syringe. 10 mL multiple-dose vial ONLY FOR RETAIL SALE BY WALMART AND ITS AFFILIATES Relion Vial ReliOn - 8-0902-31-360-1
- PRINCIPAL DISPLAY PANEL - 3 mL NovoLog PenFill NDC 0169-3303-12 List 330312 NovoLog ® PenFill ® (insulin aspart) injection For Single Patient Use Only 100 units/mL (U-100) For subcutaneous use For use with Novo Nordisk 3 mL PenFill ® cartridge compatible delivery devices and NovoFine ® disposable needles. Store refrigerated at 2°C to 8°C (36°F to 46°F) until first use. After first use store at room temperature (up to 30°C [86°F]) and discard after 28 days. Avoid freezing. Protect from light. 3 mL cartridges 5 cartridges per package Rx only NovoLog PenFill - 8-0905-31-304-6
- PRINCIPAL DISPLAY PANEL - 3 mL NovoLog FlexPen NDC 0169-6339-10 List 633910 NovoLog ® FlexPen ® Prefilled Pen (insulin aspart) injection For Single Patient Use Only 100 units/mL (U-100) 5 x 3 mL prefilled pens For subcutaneous use. For use with NovoFine ® , NovoFine ® Plus or NovoTwist ® disposable needles. Store refrigerated at 2°C to 8°C (36°F to 46°F) until first use. After first use store at room temperature (up to 30°C [86°F]) and discard after 28 days. Avoid freezing. Protect from light. Rx only Dispense in this sealed carton. FlexPen NN Brand 8-9670-31-304-8
- PRINCIPAL DISPLAY PANEL - 3 mL NovoLog FlexPen ReliOn NDC 0169-2101-25 List 210125 NovoLog ® FlexPen ® Prefilled pen (insulin aspart) injection For Single Patient Use Only 100 units/mL (U-100) 5×3 mL prefilled pens For subcutaneous use. For use with NovoFine ® , NovoFine ® Plus or NovoTwist ® disposable needles. Store refrigerated at 2°C to 8°C (36°F to 46°F) until first use. After first use store at room temperature (up to 30°C [86°F]) and discard after 28 days. Avoid freezing. Protect from light. Rx only Dispense in this sealed carton. ONLY FOR RETAIL SALES BY WALMART AND ITS AFFILIATES ReliOn FlexPen ReliOn 8-9670-31-360-3
- PRINCIPAL DISPLAY PANEL - 3 mL NovoLog FlexTouch NDC 0169-6338-10 List 633810 NovoLog ® FlexTouch ® (insulin aspart) injection For Single Patient Use Only 100 units/mL (U-100) 5 x 3 mL Prefilled Pens For subcutaneous use only Recommended for use with NovoFine ® , NovoFine ® Plus or NovoTwist ® disposable needles. Store refrigerated at 2°C to 8°C (36°F to 46°F) until first use. After first use store at room temperature (up to 30°C [86°F]) and discard after 28 days. Avoid freezing. Protect from light. Rx only Dispense in this sealed carton. NovoLog FlexTouch - 8-9500-31-301-6
- PRINCIPAL DISPLAY PANEL – Insulin Diluting Medium List: 200190 NDC 0169-2001-90 Insulin Diluting Medium for NovoLog® 10 mL multiple-dose vial Use only with NovoLog® This product does not contain insulin. Insulin Diluting Medium Carton - 8-0909-31-306-2
Packages (0)
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Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "de82c22d-ea25-44ef-8bcd-c3cda9e84e59", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["059QF0KO0R", "D933668QVX"], "rxcui": ["311040", "351926", "1653196", "1653198", "1653202", "1653204"], "spl_set_id": ["3a1e73a2-3009-40d0-876c-b4cb2be56fc5"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "NOVOLOG", "product_id": "0169-6338_de82c22d-ea25-44ef-8bcd-c3cda9e84e59", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "0169-6338", "generic_name": "insulin aspart", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NOVOLOG", "active_ingredients": [{"name": "INSULIN ASPART", "strength": "100 [iU]/mL"}], "application_number": "BLA020986", "marketing_category": "BLA", "marketing_start_date": "20131031", "listing_expiration_date": "20261231"}