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 300 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-1166
Product ID 63629-1166_bd6d03a3-c34b-4817-a263-0bc27dd645fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075215
Listing Expiration 2026-12-31
Marketing Start 2019-11-22

Pharmacologic Class

Established (EPC)
beta-adrenergic blocker [epc]
Mechanism of Action
adrenergic beta-antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636291166
Hyphenated Format 63629-1166

Supplemental Identifiers

RxCUI
896766
UNII
R5H8897N95
NUI
N0000000161 N0000175556

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 ANDA075215 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (63629-1166-1)
source: ndc

Packages (1)

63629-1166-1 500 TABLET, FILM COATED in 1 BOTTLE (63629-1166-1)

Ingredients (1)

labetalol (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": "bd6d03a3-c34b-4817-a263-0bc27dd645fa", "openfda": {"nui": ["N0000000161", "N0000175556"], "unii": ["R5H8897N95"], "rxcui": ["896766"], "spl_set_id": ["5a39bb96-4a60-49e8-859c-16bda0fe18e4"], "pharm_class_epc": ["beta-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic beta-Antagonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (63629-1166-1)", "package_ndc": "63629-1166-1", "marketing_start_date": "20191122"}], "brand_name": "Labetalol Hydrochloride", "product_id": "63629-1166_bd6d03a3-c34b-4817-a263-0bc27dd645fa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "63629-1166", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL", "strength": "300 mg/1"}], "application_number": "ANDA075215", "marketing_category": "ANDA", "marketing_start_date": "20191122", "listing_expiration_date": "20261231"}