NDC 63629-2974

Ketorolac Tromethamine

Ketorolac Tromethamine

Ketorolac Tromethamine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Ketorolac Tromethamine.

Product ID63629-2974_6d4bb4df-60c0-45dc-bde6-74592e65e7a0
NDC63629-2974
Product TypeHuman Prescription Drug
Proprietary NameKetorolac Tromethamine
Generic NameKetorolac Tromethamine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1998-06-17
Marketing CategoryANDA / ANDA
Application NumberANDA074754
Labeler NameBryant Ranch Prepack
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 Through2021-12-31

Packaging

NDC 63629-2974-0

3 TABLET, FILM COATED in 1 BOTTLE (63629-2974-0)
Marketing Start Date2005-10-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-2974-0 [63629297400]

Ketorolac Tromethamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-11
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-2974-6 [63629297406]

Ketorolac Tromethamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-10-11
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-2974-4 [63629297404]

Ketorolac Tromethamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-10-11
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-2974-5 [63629297405]

Ketorolac Tromethamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-10-11
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-2974-8 [63629297408]

Ketorolac Tromethamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-11
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-2974-2 [63629297402]

Ketorolac Tromethamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-10-11
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-2974-1 [63629297401]

Ketorolac Tromethamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-10-11
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-2974-9 [63629297409]

Ketorolac Tromethamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-11
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-2974-3 [63629297403]

Ketorolac Tromethamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-10-11
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63629-2974-7 [63629297407]

Ketorolac Tromethamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074754
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-10-11
Inactivation Date2020-01-31
Reactivation Date2020-02-25

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE10 mg/1

OpenFDA Data

SPL SET ID:f713500a-20b8-8e20-c4cc-956805170335
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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