NDC 69344-144

Sprix

Ketorolac Tromethamine

Sprix is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Zyla Life Sciences Us Inc.. The primary component is Ketorolac Tromethamine.

Product ID69344-144_1f065de3-53cf-4ca6-ae6d-a5e0742bc081
NDC69344-144
Product TypeHuman Prescription Drug
Proprietary NameSprix
Generic NameKetorolac Tromethamine
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2011-04-26
Marketing CategoryNDA / NDA
Application NumberNDA022382
Labeler NameZyla Life Sciences US Inc.
Substance NameKETOROLAC TROMETHAMINE
Active Ingredient Strength16 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 Through2022-12-31

Packaging

NDC 69344-144-43

5 CARTON in 1 CARTON (69344-144-43) > 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) > 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)
Marketing Start Date2011-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69344-144-53 [69344014453]

Sprix SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA022382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-26

NDC 69344-144-43 [69344014443]

Sprix SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA022382
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-04-26

NDC 69344-144-63 [69344014463]

Sprix SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA022382
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-04-26

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE15.75 mg/1

OpenFDA Data

SPL SET ID:97005a1c-167e-4676-bae7-e49b38c36f9e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797855
  • 1797857
  • 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 "Sprix" or generic name "Ketorolac Tromethamine"

    NDCBrand NameGeneric Name
    69344-144SprixSprix
    76519-1017SprixSprix
    0023-2181AcularKetorolac Tromethamine
    0023-9277ACULAR LSKetorolac Tromethamine
    0023-3507ACUVAILketorolac tromethamine
    0093-0314Ketorolac TromethamineKetorolac Tromethamine
    0338-0069KETOROLAC TROMETHAMINEketorolac tromethamine
    0338-0072KETOROLAC TROMETHAMINEketorolac tromethamine
    0338-0076KETOROLAC TROMETHAMINEketorolac tromethamine
    0378-1134Ketorolac TromethamineKetorolac Tromethamine

    Trademark Results [Sprix]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SPRIX
    SPRIX
    97291727 not registered Live/Pending
    Sprix, Ltd.
    2022-03-02
    SPRIX
    SPRIX
    85693913 5362215 Live/Registered
    SPRIX Co., Ltd.
    2012-08-02
    SPRIX
    SPRIX
    77172987 3550920 Live/Registered
    ZYLA LIFE SCIENCES US INC.
    2007-05-04

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