ketorolac tromethamine

Generic: ketorolac tromethamine

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

Drug Facts

Product Profile

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

ketorolac tromethamine 60 mg/2mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-272
Product ID 76420-272_e7aa72fc-eb56-e9e2-e053-2a95a90a2df2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204216
Listing Expiration 2026-12-31
Marketing Start 2019-03-18

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 76420272
Hyphenated Format 76420-272

Supplemental Identifiers

RxCUI
1665459
UNII
4EVE5946BQ

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 ANDA204216 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 60 mg/2mL
source: ndc
Packaging
  • 2 mL in 1 VIAL (76420-272-02)
source: ndc

Packages (1)

76420-272-02 2 mL in 1 VIAL (76420-272-02)

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": "e7aa72fc-eb56-e9e2-e053-2a95a90a2df2", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["1665459"], "spl_set_id": ["ee44c322-4b4b-4397-a1a5-e5b3c3c5a053"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL (76420-272-02)", "package_ndc": "76420-272-02", "marketing_start_date": "20220902"}], "brand_name": "Ketorolac tromethamine", "product_id": "76420-272_e7aa72fc-eb56-e9e2-e053-2a95a90a2df2", "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": "76420-272", "generic_name": "Ketorolac tromethamine", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "60 mg/2mL"}], "application_number": "ANDA204216", "marketing_category": "ANDA", "marketing_start_date": "20190318", "listing_expiration_date": "20261231"}