labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 300 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2054
Product ID 63629-2054_a42669d6-2662-4689-bfe7-d8e1034005ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207863
Listing Expiration 2026-12-31
Marketing Start 2019-05-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636292054
Hyphenated Format 63629-2054

Supplemental Identifiers

RxCUI
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 hydrochloride (source: ndc)
Generic Name labetalol hydrochloride (source: ndc)
Application Number ANDA207863 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (63629-2054-1)
source: ndc

Packages (1)

63629-2054-1 100 TABLET, FILM COATED in 1 BOTTLE (63629-2054-1)

Ingredients (1)

labetalol hydrochloride (300 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": "a42669d6-2662-4689-bfe7-d8e1034005ad", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896766"], "spl_set_id": ["b25c0287-1709-4859-93b4-4ea18801d19f"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (63629-2054-1)", "package_ndc": "63629-2054-1", "marketing_start_date": "20210126"}], "brand_name": "Labetalol Hydrochloride", "product_id": "63629-2054_a42669d6-2662-4689-bfe7-d8e1034005ad", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "63629-2054", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA207863", "marketing_category": "ANDA", "marketing_start_date": "20190524", "listing_expiration_date": "20261231"}