NDC 0065-0246

Betoptic S

Betaxolol Hydrochloride

Betoptic S is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Betaxolol Hydrochloride.

• Product ID: 0065-0246_113338b2-31dd-427a-a4d2-5740c0204359
• NDC: 0065-0246
• Product Type: Human Prescription Drug
• Proprietary Name: Betoptic S
• Generic Name: Betaxolol Hydrochloride
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1996-01-15
• Marketing Category: NDA / NDA
• Application Number: NDA019845
• Labeler Name: Alcon Laboratories, Inc.
• Substance Name: BETAXOLOL HYDROCHLORIDE
• Active Ingredient Strength: 3 mg/mL
• Pharm Classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0065-0246-10

1 BOTTLE, PLASTIC in 1 CARTON (0065-0246-10) > 10 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 1996-01-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-0246-05 [00065024605]

Betoptic S SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019845
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-01-15
• Marketing End Date: 2011-12-31

NDC 0065-0246-10 [00065024610]

Betoptic S SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019845
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1996-01-15

NDC 0065-0246-25 [00065024625]

Betoptic S SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019845
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-01-15
• Marketing End Date: 2011-09-20

NDC 0065-0246-20 [00065024620]

Betoptic S SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019845
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-01-15
• Marketing End Date: 2011-09-20

NDC 0065-0246-15 [00065024615]

Betoptic S SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019845
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1996-01-15

Drug Details

Active Ingredients

Ingredient	Strength
BETAXOLOL HYDROCHLORIDE	2.8 mg/mL

OpenFDA Data

• SPL SET ID: 71659a34-efad-4147-81c7-da10985e9224
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • 6X97D2XT0O
• RxNorm Concept Unique ID - RxCUI:
  • 213729
  • 308719

Pharmacological Class

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

NDC Crossover Matching brand name "Betoptic S" or generic name "Betaxolol Hydrochloride"

NDC	Brand Name	Generic Name
0065-0246	Betoptic S	betaxolol hydrochloride
0078-0729	Betoptic S	betaxolol hydrochloride
17478-705	Betaxolol	Betaxolol Hydrochloride
10702-013	BETAXOLOL HYDROCHLORIDE	betaxolol hydrochloride
10702-014	BETAXOLOL HYDROCHLORIDE	betaxolol hydrochloride
61314-245	Betaxolol Hydrochloride	Betaxolol Hydrochloride