labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 200 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6778
Product ID 50090-6778_5482004c-a140-496c-bc1d-ec9cb91926c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075133
Listing Expiration 2026-12-31
Marketing Start 1998-08-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906778
Hyphenated Format 50090-6778

Supplemental Identifiers

RxCUI
896762
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 ANDA075133 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-6778-0)
source: ndc

Packages (1)

50090-6778-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-6778-0)

Ingredients (1)

labetalol hydrochloride (200 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": "5482004c-a140-496c-bc1d-ec9cb91926c7", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896762"], "spl_set_id": ["83a6e770-207a-46bc-992d-c1ad90d1006d"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-6778-0)", "package_ndc": "50090-6778-0", "marketing_start_date": "20231025"}], "brand_name": "Labetalol hydrochloride", "product_id": "50090-6778_5482004c-a140-496c-bc1d-ec9cb91926c7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "50090-6778", "generic_name": "Labetalol hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA075133", "marketing_category": "ANDA", "marketing_start_date": "19980803", "listing_expiration_date": "20261231"}