NDC 76478-001

Betimol

Timolol

Betimol is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Timolol.

Product ID76478-001_1148d491-87d2-4423-8486-4e5355e968ed
NDC76478-001
Product TypeHuman Prescription Drug
Proprietary NameBetimol
Generic NameTimolol
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-01-02
Marketing CategoryNDA / NDA
Application NumberNDA020439
Labeler NameAkorn
Substance NameTIMOLOL
Active Ingredient Strength3 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 76478-001-05

1 BOTTLE in 1 CARTON (76478-001-05) > 5 mL in 1 BOTTLE
Marketing Start Date2014-01-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76478-001-05 [76478000105]

Betimol SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA020439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-01-02

NDC 76478-001-15 [76478000115]

Betimol SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA020439
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-02

NDC 76478-001-10 [76478000110]

Betimol SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA020439
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-02

Drug Details

Active Ingredients

IngredientStrength
TIMOLOL2.56 mg/mL

OpenFDA Data

SPL SET ID:3d7acd55-33b1-4a24-99ae-01f87b0dca1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1992305
  • 1992303
  • 208560
  • 1923428
  • UPC Code
  • 0376478001055
  • 0376478002052
  • Pharmacological Class

    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]
    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]

    NDC Crossover Matching brand name "Betimol" or generic name "Timolol"

    NDCBrand NameGeneric Name
    68669-522Betimoltimolol
    68669-525Betimoltimolol
    76478-001BetimolTimolol
    76478-002BetimolTimolol
    82584-001BETIMOLtimolol
    82584-002BETIMOLtimolol
    17478-189Timolol MaleateTimolol
    17478-365Timolol MaleateTimolol
    17478-366Timolol MaleateTimolol

    Trademark Results [Betimol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BETIMOL
    BETIMOL
    79128616 4442019 Live/Registered
    Akorn International S.à.r.l.
    2013-02-15
    BETIMOL
    BETIMOL
    74628335 1961729 Live/Registered
    AKORN INTERNATIONAL S.A.R.L.
    1995-02-01

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