NDC 51662-1295

KETOROLAC TROMETHAM

Ketorolac Trometham

KETOROLAC TROMETHAM is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hf Acquisition Co Llc, Dba Healthfirst. The primary component is Ketorolac Tromethamine.

Product ID51662-1295_76902ec7-bdc7-6fbc-e053-2991aa0a6a74
NDC51662-1295
Product TypeHuman Prescription Drug
Proprietary NameKETOROLAC TROMETHAM
Generic NameKetorolac Trometham
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2018-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA074802
Labeler NameHF Acquisition Co LLC, DBA HealthFirst
Substance NameKETOROLAC TROMETHAMINE
Active Ingredient Strength60 mg/2mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51662-1295-1

2 mL in 1 VIAL, SINGLE-DOSE (51662-1295-1)
Marketing Start Date2018-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51662-1295-1 [51662129501]

KETOROLAC TROMETHAM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074802
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-19
Inactivation Date2020-01-31
Reactivation Date2020-02-07

NDC 51662-1295-2 [51662129502]

KETOROLAC TROMETHAM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074802
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

NDC 51662-1295-3 [51662129503]

KETOROLAC TROMETHAM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074802
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-29

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE60 mg/2mL

OpenFDA Data

SPL SET ID:76446045-3cca-0206-e053-2a91aa0a2440
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1665461
  • 1665459
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Cyclooxygenase Inhibitor [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

    NDC Crossover Matching brand name "KETOROLAC TROMETHAM" or generic name "Ketorolac Trometham"

    NDCBrand NameGeneric Name
    51662-1292KETOROLAC TROMETHAMKETOROLAC TROMETHAM
    51662-1295KETOROLAC TROMETHAMKETOROLAC TROMETHAM

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