NDC 21695-463

ACULAR

Ketorolac Tromethamine

ACULAR is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Ketorolac Tromethamine.

Product ID21695-463_8014fa52-6180-4365-8285-0943a036a6f6
NDC21695-463
Product TypeHuman Prescription Drug
Proprietary NameACULAR
Generic NameKetorolac Tromethamine
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date1992-11-09
Marketing CategoryNDA / NDA
Application NumberNDA019700
Labeler NameRebel Distributors Corp.
Substance NameKETOROLAC TROMETHAMINE
Active Ingredient Strength5 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 Through2017-12-31

Packaging

NDC 21695-463-05

5 mL in 1 BOTTLE (21695-463-05)
Marketing Start Date1992-11-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-463-05 [21695046305]

ACULAR SOLUTION
Marketing CategoryNDA
Application NumberNDA019700
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1992-11-09
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE5 mg/mL

OpenFDA Data

SPL SET ID:8014fa52-6180-4365-8285-0943a036a6f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860109
  • 860107

    • Pharmacological Class

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

    NDC Crossover Matching brand name "ACULAR" or generic name "Ketorolac Tromethamine"

    NDCBrand NameGeneric Name
    0023-2181AcularKetorolac Tromethamine
    21695-463ACULARACULAR
    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 [ACULAR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ACULAR
    ACULAR
    73790634 1574303 Live/Registered
    SYNTEX (U.S.A.) INC.
    1989-04-03
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