labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol 100 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4201
Product ID 70518-4201_3ff4f9b1-7aa2-e196-e063-6294a90ae2e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075215
Listing Expiration 2026-12-31
Marketing Start 2024-10-02

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 705184201
Hyphenated Format 70518-4201

Supplemental Identifiers

RxCUI
896758
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
  • 100 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4201-0)
source: ndc

Packages (1)

70518-4201-0 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4201-0)

Ingredients (1)

labetalol (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": "3ff4f9b1-7aa2-e196-e063-6294a90ae2e6", "openfda": {"nui": ["N0000000161", "N0000175556"], "unii": ["R5H8897N95"], "rxcui": ["896758"], "spl_set_id": ["e2e50571-d8c1-43e7-b90f-877ba1c35c9b"], "pharm_class_epc": ["beta-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic beta-Antagonists [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4201-0)", "package_ndc": "70518-4201-0", "marketing_start_date": "20241002"}], "brand_name": "Labetalol Hydrochloride", "product_id": "70518-4201_3ff4f9b1-7aa2-e196-e063-6294a90ae2e6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70518-4201", "generic_name": "Labetalol Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL", "strength": "100 mg/1"}], "application_number": "ANDA075215", "marketing_category": "ANDA", "marketing_start_date": "20241002", "listing_expiration_date": "20261231"}