NDC 0409-3796

Ketorolac Tromethamine

Ketorolac Tromethamine

Ketorolac Tromethamine is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Ketorolac Tromethamine.

Product ID0409-3796_070eb5ae-202d-4d6c-a1d3-0e656aa67eaa
NDC0409-3796
Product TypeHuman Prescription Drug
Proprietary NameKetorolac Tromethamine
Generic NameKetorolac Tromethamine
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2015-10-30
Marketing CategoryANDA / ANDA
Application NumberANDA074802
Labeler NameHospira, Inc.
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 0409-3796-01

25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3796-01) > 2 mL in 1 VIAL, SINGLE-DOSE (0409-3796-19)
Marketing Start Date2015-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-3796-19 [00409379619]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074802
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-04-07

NDC 0409-3796-61 [00409379661]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074802
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-07-29
Marketing End Date2014-05-12

NDC 0409-3796-49 [00409379649]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074802
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-11-16
Marketing End Date2016-02-01

NDC 0409-3796-01 [00409379601]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074802
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-30

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE60 mg/2mL

OpenFDA Data

SPL SET ID:8accbb78-fc64-45d5-69b0-35c23a1d2a2e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1665461
  • 1665459
  • 860092

    • 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 Tromethamine" or generic name "Ketorolac Tromethamine"

    NDCBrand NameGeneric Name
    0093-0314Ketorolac TromethamineKetorolac Tromethamine
    0338-0069KETOROLAC TROMETHAMINEketorolac tromethamine
    0338-0072KETOROLAC TROMETHAMINEketorolac tromethamine
    0338-0076KETOROLAC TROMETHAMINEketorolac tromethamine
    0378-1134Ketorolac TromethamineKetorolac Tromethamine
    0409-3796Ketorolac TromethamineKetorolac Tromethamine
    0409-3793Ketorolac TromethamineKetorolac Tromethamine
    0409-3795Ketorolac TromethamineKetorolac Tromethamine
    68071-1787Ketorolac TromethamineKetorolac Tromethamine
    68071-1785Ketorolac TromethamineKetorolac Tromethamine
    68083-132ketorolac tromethamineketorolac tromethamine
    68083-104Ketorolac TromethamineKetorolac Tromethamine
    68083-134ketorolac tromethamineketorolac tromethamine
    68083-103Ketorolac TromethamineKetorolac Tromethamine
    68071-4811Ketorolac TromethamineKetorolac Tromethamine
    68083-133ketorolac tromethamineketorolac tromethamine
    68151-0098Ketorolac TromethamineKetorolac Tromethamine
    68387-440Ketorolac TromethamineKetorolac Tromethamine
    0517-0902Ketorolac TromethamineKetorolac Tromethamine
    0517-0801Ketorolac TromethamineKetorolac Tromethamine
    68788-9321Ketorolac TromethamineKetorolac Tromethamine
    0517-0601Ketorolac TromethamineKetorolac Tromethamine
    68788-7384Ketorolac TromethamineKetorolac Tromethamine
    68788-9205Ketorolac TromethamineKetorolac Tromethamine
    69543-386Ketorolac TromethamineKetorolac Tromethamine
    69543-407Ketorolac TromethamineKetorolac Tromethamine
    0548-9021Ketorolac TromethamineKetorolac Tromethamine
    69543-388Ketorolac TromethamineKetorolac Tromethamine
    69543-405Ketorolac TromethamineKetorolac Tromethamine
    70518-0048Ketorolac TromethamineKetorolac Tromethamine
    70518-1091Ketorolac TromethamineKetorolac Tromethamine
    70518-1165Ketorolac TromethamineKetorolac Tromethamine
    70518-1159Ketorolac TromethamineKetorolac Tromethamine
    70518-1669Ketorolac TromethamineKetorolac Tromethamine
    70518-1239Ketorolac TromethamineKetorolac Tromethamine
    70518-1074Ketorolac TromethamineKetorolac Tromethamine
    70518-1340Ketorolac TromethamineKetorolac Tromethamine
    70518-1889Ketorolac TromethamineKetorolac Tromethamine
    70860-700Ketorolac TromethamineKetorolac Tromethamine
    70860-701Ketorolac TromethamineKetorolac Tromethamine
    70934-029Ketorolac TromethamineKetorolac Tromethamine
    71205-116Ketorolac TromethamineKetorolac Tromethamine
    71872-7131Ketorolac TromethamineKetorolac Tromethamine
    71872-7022Ketorolac TromethamineKetorolac Tromethamine
    71872-7118Ketorolac TromethamineKetorolac Tromethamine
    71872-7119Ketorolac TromethamineKetorolac Tromethamine
    71872-7132Ketorolac TromethamineKetorolac Tromethamine
    72266-118ketorolac tromethamineketorolac tromethamine
    72266-119ketorolac tromethamineketorolac tromethamine
    76045-104Ketorolac TromethamineKetorolac Tromethamine
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