NDC 12634-809

Ketorolac Tromethamine

Ketorolac Tromethamine

Ketorolac Tromethamine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Apotheca, Inc. The primary component is Ketorolac Tromethamine.

Product ID12634-809_69956c5a-014b-4e75-b4c1-6e51d7e80315
NDC12634-809
Product TypeHuman Prescription Drug
Proprietary NameKetorolac Tromethamine
Generic NameKetorolac Tromethamine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2005-10-25
Marketing CategoryANDA / ANDA
Application NumberANDA074754
Labeler NameApotheca, Inc
Substance NameKETOROLAC TROMETHAMINE
Active Ingredient Strength10 mg/1
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 12634-809-85

15 TABLET in 1 BOTTLE (12634-809-85)
Marketing Start Date2005-10-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-809-80 [12634080980]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-79 [12634080979]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-25 [12634080925]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-65 [12634080965]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-95 [12634080995]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-91 [12634080991]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-61 [12634080961]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-60 [12634080960]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-85 [12634080985]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-59 [12634080959]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-01 [12634080901]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-57 [12634080957]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-71 [12634080971]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-55 [12634080955]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-96 [12634080996]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-66 [12634080966]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

NDC 12634-809-00 [12634080900]

Ketorolac Tromethamine TABLET
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE10 mg/1

OpenFDA Data

SPL SET ID:e20df5b6-84da-4715-b36e-bb7e4be55416
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 834022

    • 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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