NDC 0517-0801

Ketorolac Tromethamine

Ketorolac Tromethamine

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

Product ID0517-0801_75dc1361-b8f8-44ac-980d-47c08d7307cf
NDC0517-0801
Product TypeHuman Prescription Drug
Proprietary NameKetorolac Tromethamine
Generic NameKetorolac Tromethamine
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2008-05-30
Marketing CategoryANDA / ANDA
Application NumberANDA078145
Labeler NameAmerican Regent, Inc.
Substance NameKETOROLAC TROMETHAMINE
Active Ingredient Strength30 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 0517-0801-25

25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0801-25) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2008-05-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-0801-10 [00517080110]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30
Marketing End Date2010-05-31

NDC 0517-0801-25 [00517080125]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-30
Marketing End Date2010-05-31

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE30 mg/mL

OpenFDA Data

SPL SET ID:bb3cb6eb-5f5e-4389-81df-2095198c0565
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1665461
  • 1665459
  • 860092
  • UPC Code
  • 0305170902100
  • 0305170801106
  • 0305170601256
  • 0305170601102
  • 0305170801250
  • 0305170902254
  • 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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