ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

ketorolac tromethamine 60 mg/2mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-3796
Product ID 0409-3796_39818912-fe5a-4c06-8148-13bf1884e0ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074802
Listing Expiration 2027-12-31
Marketing Start 2015-10-30

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitor [epc] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04093796
Hyphenated Format 0409-3796

Supplemental Identifiers

RxCUI
860092 1665459 1665461
UNII
4EVE5946BQ

Packaging Origin

Original Packager
true

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 ketorolac tromethamine (source: ndc)
Generic Name ketorolac tromethamine (source: ndc)
Application Number ANDA074802 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 60 mg/2mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3796-01) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-3796-19)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (0409-3796-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-3796-19)
source: ndc

Packages (2)

0409-3796-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3796-01) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-3796-19) 0409-3796-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0409-3796-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-3796-19)

Ingredients (1)

ketorolac tromethamine (60 mg/2mL)

Linked Drug Pages (1)

Ketorolac Tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "39818912-fe5a-4c06-8148-13bf1884e0ca", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665459", "1665461"], "spl_set_id": ["8accbb78-fc64-45d5-69b0-35c23a1d2a2e"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3796-01)  / 2 mL in 1 VIAL, SINGLE-DOSE (0409-3796-19)", "package_ndc": "0409-3796-01", "marketing_start_date": "20151030"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (0409-3796-25)  / 2 mL in 1 VIAL, SINGLE-DOSE (0409-3796-19)", "package_ndc": "0409-3796-25", "marketing_start_date": "20250127"}], "brand_name": "Ketorolac Tromethamine", "product_id": "0409-3796_39818912-fe5a-4c06-8148-13bf1884e0ca", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0409-3796", "generic_name": "KETOROLAC TROMETHAMINE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "60 mg/2mL"}], "application_number": "ANDA074802", "marketing_category": "ANDA", "marketing_start_date": "20151030", "listing_expiration_date": "20271231"}