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 ID: 76478-001_1148d491-87d2-4423-8486-4e5355e968ed
• NDC: 76478-001
• Product Type: Human Prescription Drug
• Proprietary Name: Betimol
• Generic Name: Timolol
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2014-01-02
• Marketing Category: NDA / NDA
• Application Number: NDA020439
• Labeler Name: Akorn
• Substance Name: TIMOLOL
• Active Ingredient Strength: 3 mg/mL
• Pharm Classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 76478-001-05

1 BOTTLE in 1 CARTON (76478-001-05) > 5 mL in 1 BOTTLE

• Marketing Start Date: 2014-01-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76478-001-05 [76478000105]

Betimol SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA020439
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-01-02

NDC 76478-001-15 [76478000115]

Betimol SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA020439
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-01-02

NDC 76478-001-10 [76478000110]

Betimol SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA020439
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-01-02

Drug Details

Active Ingredients

Ingredient	Strength
TIMOLOL	2.56 mg/mL

OpenFDA Data

• SPL SET ID: 3d7acd55-33b1-4a24-99ae-01f87b0dca1f
• Manufacturer:
  • Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) (968937719)
• UNII:
  • 817W3C6175
• 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"

NDC	Brand Name	Generic Name
68669-522	Betimol	timolol
68669-525	Betimol	timolol
76478-001	Betimol	Timolol
76478-002	Betimol	Timolol
82584-001	BETIMOL	timolol
82584-002	BETIMOL	timolol
17478-189	Timolol Maleate	Timolol
17478-365	Timolol Maleate	Timolol
17478-366	Timolol Maleate	Timolol