labetalol hcl

Generic: labetalol hydrochloride

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

Drug Facts

Product Profile

Brand Name labetalol hcl
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 50090-1290
Product ID 50090-1290_0797ccb6-b00c-4ee4-91f3-a55705048b96
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200908
Listing Expiration 2026-12-31
Marketing Start 2012-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500901290
Hyphenated Format 50090-1290

Supplemental Identifiers

RxCUI
896758 896762 896766
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 hcl (source: ndc)
Generic Name labetalol hydrochloride (source: ndc)
Application Number ANDA200908 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1290-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1290-1)
source: ndc

Packages (2)

50090-1290-0 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1290-0) 50090-1290-1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1290-1)

Ingredients (1)

labetalol hydrochloride (200 mg/1)

Linked Drug Pages (1)

Labetalol HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0797ccb6-b00c-4ee4-91f3-a55705048b96", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["312dde0d-5147-483e-968f-4e0d46114176"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1290-0)", "package_ndc": "50090-1290-0", "marketing_start_date": "20141128"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1290-1)", "package_ndc": "50090-1290-1", "marketing_start_date": "20150806"}], "brand_name": "Labetalol HCL", "product_id": "50090-1290_0797ccb6-b00c-4ee4-91f3-a55705048b96", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "50090-1290", "generic_name": "Labetalol Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol HCL", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA200908", "marketing_category": "ANDA", "marketing_start_date": "20120724", "listing_expiration_date": "20261231"}