ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

ketorolac tromethamine 30 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6043
Product ID 0641-6043_25d6c438-45d2-4162-91c2-b5caa0f86bf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075772
Listing Expiration 2026-12-31
Marketing Start 2004-07-21

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 06416043
Hyphenated Format 0641-6043

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 ANDA075772 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0641-6043-25) / 2 mL in 1 VIAL (0641-6043-01)
source: ndc

Packages (1)

0641-6043-25 25 VIAL in 1 CARTON (0641-6043-25) / 2 mL in 1 VIAL (0641-6043-01)

Ingredients (1)

ketorolac tromethamine (30 mg/mL)

Linked Drug Pages (1)

Ketorolac Tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "25d6c438-45d2-4162-91c2-b5caa0f86bf3", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665459", "1665461"], "spl_set_id": ["0c2c75c9-ed7b-46a8-9543-429bf2d8f090"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-6043-25)  / 2 mL in 1 VIAL (0641-6043-01)", "package_ndc": "0641-6043-25", "marketing_start_date": "20040721"}], "brand_name": "Ketorolac Tromethamine", "product_id": "0641-6043_25d6c438-45d2-4162-91c2-b5caa0f86bf3", "dosage_form": "INJECTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0641-6043", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "30 mg/mL"}], "application_number": "ANDA075772", "marketing_category": "ANDA", "marketing_start_date": "20040721", "listing_expiration_date": "20261231"}