labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: nucare pharmaceuticals , inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

labetalol hydrochloride 200 mg/1

Manufacturer
NuCare Pharmaceuticals , Inc.

Identifiers & Regulatory

Product NDC 68071-3878
Product ID 68071-3878_3aff7330-cc8b-fa0f-e063-6294a90aa751
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209603
Listing Expiration 2026-12-31
Marketing Start 2021-05-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713878
Hyphenated Format 68071-3878

Supplemental Identifiers

RxCUI
896762
UPC
0368071387896
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 (68071-3878-9)
source: ndc

Packages (1)

68071-3878-9 90 TABLET, FILM COATED in 1 BOTTLE (68071-3878-9)

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": "3aff7330-cc8b-fa0f-e063-6294a90aa751", "openfda": {"upc": ["0368071387896"], "unii": ["1GEV3BAW9J"], "rxcui": ["896762"], "spl_set_id": ["3aff731f-1eec-19b5-e063-6294a90a3143"], "manufacturer_name": ["NuCare Pharmaceuticals , Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68071-3878-9)", "package_ndc": "68071-3878-9", "marketing_start_date": "20250728"}], "brand_name": "Labetalol Hydrochloride", "product_id": "68071-3878_3aff7330-cc8b-fa0f-e063-6294a90aa751", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68071-3878", "generic_name": "Labetalol Hydrochloride", "labeler_name": "NuCare Pharmaceuticals , 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": "20210527", "listing_expiration_date": "20261231"}