LABETALOL HYDROCHLORIDE

Product NDC: 60760-784
11-digit product format: 607600784
Labeler code: 60760
Product ID: 60760-784_ed2293f8-2b83-c3db-e053-2995a90ad46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA211953
Marketing category: ANDA
Marketing start: 2022-10-25
Substance: LABETALOL HYDROCHLORIDE
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: 60760-784_ed2293f8-2b83-c3db-e053-2995a90ad46c
SPL ID: ed2293f8-2b83-c3db-e053-2995a90ad46c
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: 2022-10-25
Marketing category: ANDA
Application number: ANDA211953
Pharmacologic classes: Adrenergic beta-Antagonists [MoA]; beta-Adrenergic Blocker [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
LABETALOL HYDROCHLORIDE	100 mg/1

Field	Values
Unii	1GEV3BAW9J
Rxcui	896758
Spl Set Id	ed2293f8-2b82-c3db-e053-2995a90ad46c
Manufacturer Name	ST. MARY'S MEDICAL PARK PHARMACY

Package NDC	Description	Marketing start	Sample
60760-784-90	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-784-90)	2022-10-25	No

UNII	Preferred term	Registry number	Matched term
1GEV3BAW9J	LABETALOL HYDROCHLORIDE	32780-64-6	LABETALOL HYDROCHLORIDE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
60760-784-90	60760078490	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-784-90)	2022-10-25	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets USP Rx only	ST. MARY'S MEDICAL PARK PHARMACY	2022-11-10	HUMAN PRESCRIPTION DRUG LABEL	1