ketorolac tromethamine

Generic: ketorolac tromethamine

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

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler camber pharmaceuticals, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketorolac tromethamine 15 mg/mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-305
Product ID 31722-305_23a5daec-e083-eec0-e063-6394a90a2411
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217166
Listing Expiration 2026-12-31
Marketing Start 2023-06-20

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 31722305
Hyphenated Format 31722-305

Supplemental Identifiers

RxCUI
860092 1665459 1665461
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 ANDA217166 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-305-10) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-305-25) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

31722-305-10 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-305-10) / 1 mL in 1 VIAL, SINGLE-DOSE 31722-305-25 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-305-25) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ketorolac tromethamine (15 mg/mL)

Linked Drug Pages (1)

KETOROLAC TROMETHAMINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "23a5daec-e083-eec0-e063-6394a90a2411", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665459", "1665461"], "spl_set_id": ["478aff0b-29fd-43b2-a701-5236b8f8e3df"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (31722-305-10)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "31722-305-10", "marketing_start_date": "20240404"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (31722-305-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "31722-305-25", "marketing_start_date": "20230620"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "31722-305_23a5daec-e083-eec0-e063-6394a90a2411", "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": "31722-305", "generic_name": "KETOROLAC TROMETHAMINE", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOROLAC TROMETHAMINE", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "15 mg/mL"}], "application_number": "ANDA217166", "marketing_category": "ANDA", "marketing_start_date": "20230620", "listing_expiration_date": "20261231"}