NDC 0023-4385

BETAGAN

Levobunolol Hydrochloride

BETAGAN is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Levobunolol Hydrochloride.

• Product ID: 0023-4385_21d89a13-52ed-4d3b-82ff-9ef2d8f34900
• NDC: 0023-4385
• Product Type: Human Prescription Drug
• Proprietary Name: BETAGAN
• Generic Name: Levobunolol Hydrochloride
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1986-07-24
• Marketing Category: NDA / NDA
• Application Number: NDA019219
• Labeler Name: Allergan, Inc.
• Substance Name: LEVOBUNOLOL HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC SPL Data Element Entries

NDC 0023-4385-10 [00023438510]

BETAGAN SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019219
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1986-07-24
• Marketing End Date: 2019-01-30

NDC 0023-4385-15 [00023438515]

BETAGAN SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019219
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1986-07-24
• Marketing End Date: 2018-01-30

NDC 0023-4385-05 [00023438505]

BETAGAN SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019219
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1986-07-24
• Marketing End Date: 2019-02-01

Drug Details

Active Ingredients

Ingredient	Strength
LEVOBUNOLOL HYDROCHLORIDE	5 mg/mL

OpenFDA Data

• SPL SET ID: 1a32c0e8-7d10-447e-a7c4-252c98b629bd
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • O90S49LDHH
• RxNorm Concept Unique ID - RxCUI:
  • 1150838
  • 1150836

Pharmacological Class

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

NDC Crossover Matching brand name "BETAGAN" or generic name "Levobunolol Hydrochloride"

NDC	Brand Name	Generic Name
0023-4385	BETAGAN	levobunolol hydrochloride
24208-505	Levobunolol Hydrochloride	Levobunolol Hydrochloride
60758-060	LEVOBUNOLOL HYDROCHLORIDE	levobunolol hydrochloride
60758-063	LEVOBUNOLOL HYDROCHLORIDE	levobunolol hydrochloride