NDC 51662-1292

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 ID: 51662-1292_76902ec7-bdc7-6fbc-e053-2991aa0a6a74
• NDC: 51662-1292
• Product Type: Human Prescription Drug
• Proprietary Name: KETOROLAC TROMETHAM
• Generic Name: Ketorolac Trometham
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2018-09-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074802
• Labeler Name: HF Acquisition Co LLC, DBA HealthFirst
• Substance Name: KETOROLAC TROMETHAMINE
• Active Ingredient Strength: 30 mg/mL
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 51662-1292-1

1 mL in 1 VIAL, SINGLE-DOSE (51662-1292-1)

• Marketing Start Date: 2018-09-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51662-1292-1 [51662129201]

KETOROLAC TROMETHAM INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074802
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-09-19
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-07

Drug Details

Active Ingredients

Ingredient	Strength
KETOROLAC TROMETHAMINE	30 mg/mL

OpenFDA Data

• SPL SET ID: 76446045-3cca-0206-e053-2a91aa0a2440
• Manufacturer:
  • HF Acquisition Co LLC, DBA HealthFirst
• UNII:
  • 4EVE5946BQ
• 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"

NDC	Brand Name	Generic Name
51662-1292	KETOROLAC TROMETHAM	KETOROLAC TROMETHAM
51662-1295	KETOROLAC TROMETHAM	KETOROLAC TROMETHAM