NDC 10135-623

Betaxolol

Betaxolol

Betaxolol is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Betaxolol Hydrochloride.

• Product ID: 10135-623_57968420-5df5-4b0c-ab16-5bb526a908e5
• NDC: 10135-623
• Product Type: Human Prescription Drug
• Proprietary Name: Betaxolol
• Generic Name: Betaxolol
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075541
• Labeler Name: Marlex Pharmaceuticals Inc
• Substance Name: BETAXOLOL HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 10135-623-01

100 TABLET, FILM COATED in 1 BOTTLE (10135-623-01)

• Marketing Start Date: 2016-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10135-623-01 [10135062301]

Betaxolol TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA075541
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BETAXOLOL HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 4aa6e51b-80a3-4022-87e2-0692f24ae9ca
• Manufacturer:
  • Marlex Pharmaceuticals Inc
• UNII:
  • 6X97D2XT0O
• RxNorm Concept Unique ID - RxCUI:
  • 1297757
  • 1297753

Pharmacological Class

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

NDC Crossover Matching brand name "Betaxolol" or generic name "Betaxolol"

NDC	Brand Name	Generic Name
10135-623	Betaxolol	Betaxolol
10135-624	Betaxolol	Betaxolol
17478-705	Betaxolol	Betaxolol Hydrochloride
24658-700	Betaxolol	Betaxolol
24658-701	Betaxolol	Betaxolol
42806-038	Betaxolol	Betaxolol
42806-039	Betaxolol	Betaxolol
60429-753	Betaxolol	Betaxolol
60429-754	Betaxolol	Betaxolol