ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

ketorolac tromethamine 60 mg/2mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1295
Product ID 51662-1295_ae80d94a-79ae-65d8-e053-2a95a90a5dac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074802
Listing Expiration 2026-12-31
Marketing Start 2018-09-19

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 516621295
Hyphenated Format 51662-1295

Supplemental Identifiers

RxCUI
1665459 1665461
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 ANDA074802 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 60 mg/2mL
source: ndc
Packaging
  • 2 mL in 1 VIAL, SINGLE-DOSE (51662-1295-1)
  • 25 POUCH in 1 CASE (51662-1295-3) / 1 mL in 1 POUCH (51662-1295-2)
source: ndc

Packages (2)

51662-1295-1 2 mL in 1 VIAL, SINGLE-DOSE (51662-1295-1) 51662-1295-3 25 POUCH in 1 CASE (51662-1295-3) / 1 mL in 1 POUCH (51662-1295-2)

Ingredients (1)

ketorolac tromethamine (60 mg/2mL)

Linked Drug Pages (1)

KETOROLAC TROMETHAMINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "ae80d94a-79ae-65d8-e053-2a95a90a5dac", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["1665459", "1665461"], "spl_set_id": ["76446045-3cca-0206-e053-2a91aa0a2440"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL, SINGLE-DOSE (51662-1295-1)", "package_ndc": "51662-1295-1", "marketing_start_date": "20180919"}, {"sample": false, "description": "25 POUCH in 1 CASE (51662-1295-3)  / 1 mL in 1 POUCH (51662-1295-2)", "package_ndc": "51662-1295-3", "marketing_start_date": "20200429"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "51662-1295_ae80d94a-79ae-65d8-e053-2a95a90a5dac", "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": "51662-1295", "generic_name": "KETOROLAC TROMETHAMINE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOROLAC TROMETHAMINE", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "60 mg/2mL"}], "application_number": "ANDA074802", "marketing_category": "ANDA", "marketing_start_date": "20180919", "listing_expiration_date": "20261231"}