NEBIVOLOL

Product NDC: 71335-2443
11-digit product format: 713352443
Labeler code: 71335
Product ID: 71335-2443_3e583d86-66cb-4a0f-a868-416721f24ad1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nebibolol
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA212682
Marketing category: ANDA
Marketing start: 2022-02-14
Substance: NEBIVOLOL
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-2443_3e583d86-66cb-4a0f-a868-416721f24ad1
SPL ID: 3e583d86-66cb-4a0f-a868-416721f24ad1
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: NEBIVOLOL
Generic name: nebibolol
Dosage form: TABLET
Route: ORAL
Marketing start: 2022-02-14
Marketing category: ANDA
Application number: ANDA212682
Pharmacologic classes: Adrenergic beta-Antagonists [MoA]; beta-Adrenergic Blocker [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
NEBIVOLOL	10 mg/1

Package NDC	Description	Marketing start	Sample
71335-2443-1	30 TABLET in 1 BOTTLE (71335-2443-1)	2024-08-15	No
71335-2443-2	90 TABLET in 1 BOTTLE (71335-2443-2)	2024-08-15	No

UNII	Preferred term	Registry number	Matched term
030Y90569U	NEBIVOLOL	118457-14-0	NEBIVOLOL

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2443-1	71335244301	30 TABLET in 1 BOTTLE (71335-2443-1)	30 tablet	2024-08-15	No	No	Historical
71335-2443-2	71335244302	90 TABLET in 1 BOTTLE (71335-2443-2)	90 tablet	2024-08-15	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
NEBIVOLOL	Bryant Ranch Prepack	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	1