NDC 68083-132

ketorolac tromethamine

Ketorolac Tromethamine

ketorolac tromethamine is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Ketorolac Tromethamine.

Product ID68083-132_5b9415d0-77fa-4cde-8130-8268e239fce4
NDC68083-132
Product TypeHuman Prescription Drug
Proprietary Nameketorolac tromethamine
Generic NameKetorolac Tromethamine
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2016-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA204216
Labeler NameGland Pharma Limited
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 Through2022-12-31

Packaging

NDC 68083-132-10

10 VIAL in 1 CARTON (68083-132-10) > 1 mL in 1 VIAL (68083-132-01)
Marketing Start Date2016-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-132-25 [68083013225]

ketorolac tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204216
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-06

NDC 68083-132-10 [68083013210]

ketorolac tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204216
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-01

NDC 68083-132-01 [68083013201]

ketorolac tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204216
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-01

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE15 mg/mL

OpenFDA Data

SPL SET ID:5abd4389-4fb2-408b-a27e-cf64b6a921f1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1665461
  • 1665459
  • 860092
    • UPC Code
  • 0368083134105
  • 0368083133108
  • 0368083132101

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

    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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