labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 200 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-253
Product ID 29300-253_8325a41d-d05c-4c6b-b2fc-260c9380bfba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212719
Listing Expiration 2027-12-31
Marketing Start 2022-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300253
Hyphenated Format 29300-253

Supplemental Identifiers

RxCUI
896758 896762 896766
UPC
0329300254013
UNII
1GEV3BAW9J

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 ANDA212719 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (29300-253-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (29300-253-05)
source: ndc

Packages (2)

29300-253-01 100 TABLET, FILM COATED in 1 BOTTLE (29300-253-01) 29300-253-05 500 TABLET, FILM COATED in 1 BOTTLE (29300-253-05)

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": "8325a41d-d05c-4c6b-b2fc-260c9380bfba", "openfda": {"upc": ["0329300254013"], "unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["ed0188ba-3fd3-4680-a829-ba242a115fab"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (29300-253-01)", "package_ndc": "29300-253-01", "marketing_start_date": "20221001"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (29300-253-05)", "package_ndc": "29300-253-05", "marketing_start_date": "20221001"}], "brand_name": "Labetalol Hydrochloride", "product_id": "29300-253_8325a41d-d05c-4c6b-b2fc-260c9380bfba", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "29300-253", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA212719", "marketing_category": "ANDA", "marketing_start_date": "20221001", "listing_expiration_date": "20271231"}