labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: method pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler method pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol 300 mg/1

Manufacturer
Method Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 58657-908
Product ID 58657-908_46b55541-52d5-7213-e063-6294a90affc4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075215
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

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 58657908
Hyphenated Format 58657-908

Supplemental Identifiers

RxCUI
896758 896762 896766
UPC
0358657603014 0358657603502 0358657602505 0358657604509 0358657602017 0358657604011
UNII
R5H8897N95
NUI
N0000000161 N0000175556

Packaging Origin

Original Packager
true

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
  • 100 BLISTER PACK in 1 CARTON (58657-908-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (58657-908-10)
source: ndc

Packages (1)

58657-908-01 100 BLISTER PACK in 1 CARTON (58657-908-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (58657-908-10)

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": "46b55541-52d5-7213-e063-6294a90affc4", "openfda": {"nui": ["N0000000161", "N0000175556"], "upc": ["0358657603014", "0358657603502", "0358657602505", "0358657604509", "0358657602017", "0358657604011"], "unii": ["R5H8897N95"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["733d6e32-ac90-4796-bf25-9d5887c897a5"], "pharm_class_epc": ["beta-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic beta-Antagonists [MoA]"], "manufacturer_name": ["Method Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (58657-908-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (58657-908-10)", "package_ndc": "58657-908-01", "marketing_start_date": "20250701"}], "brand_name": "Labetalol Hydrochloride", "product_id": "58657-908_46b55541-52d5-7213-e063-6294a90affc4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "58657-908", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Method Pharmaceuticals, LLC", "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": "20250701", "listing_expiration_date": "20261231"}