ketorolac tromethamine

Generic: ketorolac tromethamine

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

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ketorolac tromethamine 10 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-2983
Product ID 68071-2983_33a10385-9c5e-478b-e063-6294a90a1a20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217038
Listing Expiration 2026-12-31
Marketing Start 2022-11-10

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 680712983
Hyphenated Format 68071-2983

Supplemental Identifiers

RxCUI
834022
UPC
0368071298321
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 ANDA217038 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (68071-2983-2)
  • 28 TABLET, FILM COATED in 1 BOTTLE (68071-2983-8)
source: ndc

Packages (2)

68071-2983-2 20 TABLET, FILM COATED in 1 BOTTLE (68071-2983-2) 68071-2983-8 28 TABLET, FILM COATED in 1 BOTTLE (68071-2983-8)

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": "33a10385-9c5e-478b-e063-6294a90a1a20", "openfda": {"upc": ["0368071298321"], "unii": ["4EVE5946BQ"], "rxcui": ["834022"], "spl_set_id": ["fe7eb195-48be-753b-e053-6294a90a8500"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68071-2983-2)", "package_ndc": "68071-2983-2", "marketing_start_date": "20230619"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (68071-2983-8)", "package_ndc": "68071-2983-8", "marketing_start_date": "20250425"}], "brand_name": "ketorolac tromethamine", "product_id": "68071-2983_33a10385-9c5e-478b-e063-6294a90a1a20", "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": "68071-2983", "generic_name": "ketorolac tromethamine", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ketorolac tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "10 mg/1"}], "application_number": "ANDA217038", "marketing_category": "ANDA", "marketing_start_date": "20221110", "listing_expiration_date": "20261231"}