NDC 55648-758

KETOROLAC TROMETHAMINE

Ketorolac Tromethamine

KETOROLAC TROMETHAMINE is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Ketorolac Tromethamine.

Product ID55648-758_a12b2b3e-bac4-4cd6-a104-24283bc0f02e
NDC55648-758
Product TypeHuman Prescription Drug
Proprietary NameKETOROLAC TROMETHAMINE
Generic NameKetorolac Tromethamine
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2007-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA077942
Labeler NameWOCKHARDT LIMITED
Substance NameKETOROLAC TROMETHAMINE
Active Ingredient Strength30 mg/mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 55648-758-01

25 VIAL, SINGLE-DOSE in 1 CARTON (55648-758-01) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2007-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-758-04 [55648075804]

KETOROLAC TROMETHAMINE INJECTION
Marketing CategoryANDA
Application NumberANDA077942
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-27
Inactivation Date2020-01-31

NDC 55648-758-06 [55648075806]

KETOROLAC TROMETHAMINE INJECTION
Marketing CategoryANDA
Application NumberANDA077942
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-27
Inactivation Date2020-01-31

NDC 55648-758-05 [55648075805]

KETOROLAC TROMETHAMINE INJECTION
Marketing CategoryANDA
Application NumberANDA077942
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-27
Inactivation Date2020-01-31

NDC 55648-758-03 [55648075803]

KETOROLAC TROMETHAMINE INJECTION
Marketing CategoryANDA
Application NumberANDA077942
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-12-19
Inactivation Date2020-01-31

NDC 55648-758-01 [55648075801]

KETOROLAC TROMETHAMINE INJECTION
Marketing CategoryANDA
Application NumberANDA077942
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-27
Inactivation Date2020-01-31

NDC 55648-758-02 [55648075802]

KETOROLAC TROMETHAMINE INJECTION
Marketing CategoryANDA
Application NumberANDA077942
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-27
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE30 mg/mL

OpenFDA Data

SPL SET ID:cff1fed3-1f30-4da9-93b4-8eebd0fd88b3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860096
  • 1665461
  • 1665459
  • 860092
    • UPC Code
  • 0364679757017
  • 0364679758021

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • 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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