Labetalol Hydrochloride

Product NDC: 63629-1161
11-digit product format: 636291161
Labeler code: 63629
Product ID: 63629-1161_68cf4a55-74d2-43e1-a7cd-ccc9a14c8967
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075215
Marketing category: ANDA
Marketing start: 2019-11-22
Substance: LABETALOL
Active strength: 100 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: 63629-1161_68cf4a55-74d2-43e1-a7cd-ccc9a14c8967
SPL ID: 68cf4a55-74d2-43e1-a7cd-ccc9a14c8967
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Labetalol Hydrochloride
Generic name: Labetalol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2019-11-22
Marketing category: ANDA
Application number: ANDA075215
Pharmacologic classes: Adrenergic beta-Antagonists [MoA]; beta-Adrenergic Blocker [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
LABETALOL	100 mg/1

Package NDC	Description	Marketing start	Sample
63629-1161-1	100 TABLET, FILM COATED in 1 BOTTLE (63629-1161-1)	2019-11-22	No

UNII	Preferred term	Registry number	Matched term
R5H8897N95	LABETALOL	36894-69-6	LABETALOL
1GEV3BAW9J	LABETALOL HYDROCHLORIDE	32780-64-6	Labetalol Hydrochloride

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
63629-1161-1	63629116101	100 TABLET, FILM COATED in 1 BOTTLE (63629-1161-1)	2019-11-22	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Labetalol HCl Tablets	Bryant Ranch Prepack	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	107