labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: st. mary's medical park pharmacy
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler st. mary's medical park pharmacy
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 100 mg/1

Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY

Identifiers & Regulatory

Product NDC 60760-991
Product ID 60760-991_302822c4-c396-167c-e063-6294a90a480b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209603
Listing Expiration 2026-12-31
Marketing Start 2021-05-27

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60760991
Hyphenated Format 60760-991

Supplemental Identifiers

RxCUI
896758
UNII
1GEV3BAW9J

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name labetalol hydrochloride (source: ndc)
Generic Name labetalol hydrochloride (source: ndc)
Application Number ANDA209603 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-991-90)
source: ndc

Packages (1)

60760-991-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-991-90)

Ingredients (1)

labetalol hydrochloride (100 mg/1)

Linked Drug Pages (1)

Labetalol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "302822c4-c396-167c-e063-6294a90a480b", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896758"], "spl_set_id": ["30281c4d-2fd1-167a-e063-6294a90a77c4"], "manufacturer_name": ["ST. MARY'S MEDICAL PARK PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-991-90)", "package_ndc": "60760-991-90", "marketing_start_date": "20250312"}], "brand_name": "Labetalol Hydrochloride", "product_id": "60760-991_302822c4-c396-167c-e063-6294a90a480b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "60760-991", "generic_name": "Labetalol Hydrochloride", "labeler_name": "ST. MARY'S MEDICAL PARK PHARMACY", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA209603", "marketing_category": "ANDA", "marketing_start_date": "20210527", "listing_expiration_date": "20261231"}