ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

ketorolac tromethamine 30 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-119
Product ID 84549-119_463ebf0c-f557-c4f9-e063-6394a90a614b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204216
Listing Expiration 2026-12-31
Marketing Start 2023-06-23

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 84549119
Hyphenated Format 84549-119

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
  • 30 mg/mL
source: ndc
Packaging
  • 2 mL in 1 VIAL (84549-119-25)
source: ndc

Packages (1)

84549-119-25 2 mL in 1 VIAL (84549-119-25)

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": "463ebf0c-f557-c4f9-e063-6394a90a614b", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["1665459"], "spl_set_id": ["42dfd39e-53a3-e9ee-e063-6394a90ab51e"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL (84549-119-25)", "package_ndc": "84549-119-25", "marketing_start_date": "20251010"}], "brand_name": "ketorolac tromethamine", "product_id": "84549-119_463ebf0c-f557-c4f9-e063-6394a90a614b", "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": "84549-119", "generic_name": "ketorolac tromethamine", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ketorolac tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "30 mg/mL"}], "application_number": "ANDA204216", "marketing_category": "ANDA", "marketing_start_date": "20230623", "listing_expiration_date": "20261231"}