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 hydrochloride 200 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3993
Product ID 70518-3993_3f8fc907-586d-8e31-e063-6294a90a40a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209603
Listing Expiration 2026-12-31
Marketing Start 2024-01-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183993
Hyphenated Format 70518-3993

Supplemental Identifiers

RxCUI
896762
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
  • 200 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-0)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-1)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-2)
source: ndc

Packages (3)

70518-3993-0 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-0) 70518-3993-1 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-1) 70518-3993-2 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-2)

Ingredients (1)

labetalol hydrochloride (200 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": "3f8fc907-586d-8e31-e063-6294a90a40a0", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896762"], "spl_set_id": ["5101b8dd-6148-465c-9bba-0209ce823fe5"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-0)", "package_ndc": "70518-3993-0", "marketing_start_date": "20240124"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-1)", "package_ndc": "70518-3993-1", "marketing_start_date": "20240124"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-2)", "package_ndc": "70518-3993-2", "marketing_start_date": "20250120"}], "brand_name": "Labetalol Hydrochloride", "product_id": "70518-3993_3f8fc907-586d-8e31-e063-6294a90a40a0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70518-3993", "generic_name": "Labetalol Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA209603", "marketing_category": "ANDA", "marketing_start_date": "20240124", "listing_expiration_date": "20261231"}