ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ketorolac tromethamine 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-904
Product ID 43063-904_302be0ae-863f-db7d-e063-6294a90a1f9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074754
Listing Expiration 2026-12-31
Marketing Start 1998-06-17

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 43063904
Hyphenated Format 43063-904

Supplemental Identifiers

RxCUI
834022
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 ANDA074754 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-10)
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-30)
source: ndc

Packages (4)

43063-904-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-10) 43063-904-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-15) 43063-904-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-20) 43063-904-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-30)

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": "302be0ae-863f-db7d-e063-6294a90a1f9d", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["834022"], "spl_set_id": ["add10ccd-c205-4512-9619-253290fa1152"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-10)", "package_ndc": "43063-904-10", "marketing_start_date": "20181108"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-15)", "package_ndc": "43063-904-15", "marketing_start_date": "20181211"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-20)", "package_ndc": "43063-904-20", "marketing_start_date": "20181217"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-30)", "package_ndc": "43063-904-30", "marketing_start_date": "20240910"}], "brand_name": "Ketorolac Tromethamine", "product_id": "43063-904_302be0ae-863f-db7d-e063-6294a90a1f9d", "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": "43063-904", "generic_name": "Ketorolac Tromethamine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "10 mg/1"}], "application_number": "ANDA074754", "marketing_category": "ANDA", "marketing_start_date": "19980617", "listing_expiration_date": "20261231"}