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 30 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1594
Product ID 51662-1594_0ffa38dd-8b40-d947-e063-6294a90a608e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075784
Listing Expiration 2026-12-31
Marketing Start 2022-07-22

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 516621594
Hyphenated Format 51662-1594

Supplemental Identifiers

RxCUI
1665461
UPC
0363323162009
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 ANDA075784 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 25 POUCH in 1 CASE (51662-1594-3) / 1 VIAL, SINGLE-USE in 1 POUCH (51662-1594-2) / 1 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

51662-1594-3 25 POUCH in 1 CASE (51662-1594-3) / 1 VIAL, SINGLE-USE in 1 POUCH (51662-1594-2) / 1 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

ketorolac tromethamine (30 mg/mL)

Linked Drug Pages (1)

KETOROLAC TROMETHAMINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "0ffa38dd-8b40-d947-e063-6294a90a608e", "openfda": {"upc": ["0363323162009"], "unii": ["4EVE5946BQ"], "rxcui": ["1665461"], "spl_set_id": ["e46ebc7f-584e-e2b7-e053-2995a90ad17b"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "25 POUCH in 1 CASE (51662-1594-3)  / 1 VIAL, SINGLE-USE in 1 POUCH (51662-1594-2)  / 1 mL in 1 VIAL, SINGLE-USE", "package_ndc": "51662-1594-3", "marketing_start_date": "20220722"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "51662-1594_0ffa38dd-8b40-d947-e063-6294a90a608e", "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": "51662-1594", "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": "30 mg/mL"}], "application_number": "ANDA075784", "marketing_category": "ANDA", "marketing_start_date": "20220722", "listing_expiration_date": "20261231"}