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 100 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7458
Product ID 50090-7458_f7d84175-a542-42f3-ae4c-3c4195dee521
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209603
Listing Expiration 2027-12-31
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 500907458
Hyphenated Format 50090-7458

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 (50090-7458-0)
source: ndc

Packages (1)

50090-7458-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-7458-0)

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": "f7d84175-a542-42f3-ae4c-3c4195dee521", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896758"], "spl_set_id": ["b4a5f170-a400-4986-8c64-f55d0413f0f6"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-7458-0)", "package_ndc": "50090-7458-0", "marketing_start_date": "20241114"}], "brand_name": "Labetalol Hydrochloride", "product_id": "50090-7458_f7d84175-a542-42f3-ae4c-3c4195dee521", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "50090-7458", "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": "100 mg/1"}], "application_number": "ANDA209603", "marketing_category": "ANDA", "marketing_start_date": "20210527", "listing_expiration_date": "20271231"}