insulin glargine solostar
Generic: insulin glargine
Labeler: winthrop u.s.Drug Facts
Product Profile
Brand Name
insulin glargine solostar
Generic Name
insulin glargine
Labeler
winthrop u.s.
Dosage Form
INJECTION, SOLUTION
Routes
Active Ingredients
insulin glargine 100 [iU]/mL
Manufacturer
Identifiers & Regulatory
Product NDC
0955-1728
Product ID
0955-1728_81a7552c-6a2e-4c54-9bf7-56e15f7d166d
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
BLA
Application Number
BLA021081
Marketing Start
2022-05-02
Marketing End
2026-03-31
Pharmacologic Class
Established (EPC)
Chemical Structure
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
09551728
Hyphenated Format
0955-1728
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
insulin glargine solostar (source: ndc)
Generic Name
insulin glargine (source: ndc)
Application Number
BLA021081 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 100 [iU]/mL
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Insulin Glargine injection is supplied as a clear and colorless solution containing 100 units/mL (U-100) available as follows: Insulin Glargine NDC number Package size 10 mL Multiple-dose vial 0955-1729-01 1 vial per carton 3 mL SoloStar single-patient-use prefilled pen 0955-1728-05 5 pens per carton Additional Information about Insulin Glargine Solostar: The Insulin Glargine SoloStar prefilled pen dials in 1-unit increments. Needles are not included in the packs. Use BD Ultra-Fine ® needles Other brands listed are the trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC with the SoloStar prefilled pens (these BD manufactured needles are sold separately). 16.2 Storage Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused Insulin Glargine in a refrigerator between 36°F and 46°F (2°C and 8°C). Do not freeze. Discard Insulin Glargine if it has been frozen. Protect Insulin Glargine from direct heat and light. Storage conditions are summarized in the following table. Not in-use (unopened) Not in-use (unopened) In-use (opened) Refrigerated Room Temperature (36°F–46°F [2°C–8°C]) (up to 86°F [30°C]) (see temperature below) 10 mL multiple-dose vial Until expiration date 28 days 28 days Refrigerated or room temperature 3 mL single-patient-use SoloStar prefilled pen Until expiration date 28 days 28 days Room temperature only (Do not refrigerate)
- PRINCIPAL DISPLAY PANEL - One 10 mL Vial Carton NDC 0955-1729-01 Rx only Winthrop A SANOFI COMPANY Insulin glargine injection 100 units/mL (U-100) For subcutaneous injection only Do not mix with other insulins Use only if solution is clear and colorless with no particles visible Use with U-100 syringe only One 10 mL multiple-dose vial SANOFI PRINCIPAL DISPLAY PANEL - One 10 mL Vial Carton
- PRINCIPAL DISPLAY PANEL - Five 3 mL Pen Carton Winthrop A SANOFI COMPANY NDC 0955-1728-05 Insulin glargine injection SoloStar ® For Single Patient Use Only Five 3 mL Prefilled Pens – Dispense in this sealed carton Solution for injection in a disposable insulin delivery device Do not mix with other insulins For subcutaneous injection only Use only if solution is clear and colorless with no particles visible Use within 28 days after initial use *Needles not included (see back panel) Rx ONLY 100 units/mL (U-100) SANOFI PRINCIPAL DISPLAY PANEL - Five 3 mL Pen Carton
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["SUBCUTANEOUS"], "spl_id": "81a7552c-6a2e-4c54-9bf7-56e15f7d166d", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["2ZM8CX04RZ"], "rxcui": ["311041", "847230"], "spl_set_id": ["406883ea-7f97-4eff-8d43-0bab004654f1"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["Winthrop U.S."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Insulin Glargine Solostar", "product_id": "0955-1728_81a7552c-6a2e-4c54-9bf7-56e15f7d166d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "0955-1728", "generic_name": "insulin glargine", "labeler_name": "Winthrop U.S.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Insulin Glargine Solostar", "active_ingredients": [{"name": "INSULIN GLARGINE", "strength": "100 [iU]/mL"}], "application_number": "BLA021081", "marketing_category": "BLA", "marketing_end_date": "20260331", "marketing_start_date": "20220502"}