ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler ajanta pharma usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ketorolac tromethamine 10 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-316
Product ID 27241-316_f6b3d103-c860-4256-8342-111a08b634b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215788
Listing Expiration 2026-12-31
Marketing Start 2025-01-18

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 27241316
Hyphenated Format 27241-316

Supplemental Identifiers

RxCUI
834022
UPC
0327241316012
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 ANDA215788 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (27241-316-01)
source: ndc

Packages (1)

27241-316-01 100 TABLET, FILM COATED in 1 BOTTLE (27241-316-01)

Ingredients (1)

ketorolac tromethamine (10 mg/1)

Linked Drug Pages (1)

Ketorolac Tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f6b3d103-c860-4256-8342-111a08b634b2", "openfda": {"upc": ["0327241316012"], "unii": ["4EVE5946BQ"], "rxcui": ["834022"], "spl_set_id": ["36713fb3-d301-432d-a95d-06e368fc8a22"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (27241-316-01)", "package_ndc": "27241-316-01", "marketing_start_date": "20250118"}], "brand_name": "Ketorolac Tromethamine", "product_id": "27241-316_f6b3d103-c860-4256-8342-111a08b634b2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "27241-316", "generic_name": "ketorolac tromethamine", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "10 mg/1"}], "application_number": "ANDA215788", "marketing_category": "ANDA", "marketing_start_date": "20250118", "listing_expiration_date": "20261231"}