NDC 53225-3655

ReadySharp Ketorolac

Ketorolac Tromethamine

ReadySharp Ketorolac is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Terrain Pharmaceuticals. The primary component is Ketorolac Tromethamine.

Product ID53225-3655_7c394b5d-1cfb-8780-e053-2a91aa0a1abd
NDC53225-3655
Product TypeHuman Prescription Drug
Proprietary NameReadySharp Ketorolac
Generic NameKetorolac Tromethamine
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date1997-06-05
Marketing CategoryANDA / ANDA
Application NumberANDA074802
Labeler NameTerrain Pharmaceuticals
Substance NameKETOROLAC TROMETHAMINE
Active Ingredient Strength15 mg/mL
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 53225-3655-1

1 mL in 1 VIAL (53225-3655-1)
Marketing Start Date2016-10-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53225-3655-1 [53225365501]

ReadySharp Ketorolac INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074802
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-26

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE15 mg/mL

OpenFDA Data

SPL SET ID:3fc95839-6c09-1303-e054-00144ff88e88
Manufacturer
UNII

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 "ReadySharp Ketorolac" or generic name "Ketorolac Tromethamine"

NDCBrand NameGeneric Name
53225-3655ReadySharp KetorolacReadySharp Ketorolac
68788-7439ReadySharp KetorolacReadySharp Ketorolac
0023-2181AcularKetorolac Tromethamine
0023-9277ACULAR LSKetorolac Tromethamine
0023-3507ACUVAILketorolac tromethamine
0093-0314Ketorolac TromethamineKetorolac Tromethamine
0338-0069KETOROLAC TROMETHAMINEketorolac tromethamine
0338-0072KETOROLAC TROMETHAMINEketorolac tromethamine
0338-0076KETOROLAC TROMETHAMINEketorolac tromethamine
0378-1134Ketorolac TromethamineKetorolac Tromethamine

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