labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler redpharm drug
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 300 mg/1

Manufacturer
RedPharm Drug

Identifiers & Regulatory

Product NDC 67296-2114
Product ID 67296-2114_3b0aa187-8058-8e3b-e063-6294a90a373e
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 672962114
Hyphenated Format 67296-2114

Supplemental Identifiers

RxCUI
896766
UPC
0370377061134 0370377060120
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
  • 300 mg/1
source: ndc
Packaging
  • 21 TABLET, FILM COATED in 1 BOTTLE (67296-2114-2)
  • 60 TABLET, FILM COATED in 1 BOTTLE (67296-2114-6)
source: ndc

Packages (2)

67296-2114-2 21 TABLET, FILM COATED in 1 BOTTLE (67296-2114-2) 67296-2114-6 60 TABLET, FILM COATED in 1 BOTTLE (67296-2114-6)

Ingredients (1)

labetalol hydrochloride (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": "3b0aa187-8058-8e3b-e063-6294a90a373e", "openfda": {"upc": ["0370377061134", "0370377060120"], "unii": ["1GEV3BAW9J"], "rxcui": ["896766"], "spl_set_id": ["1e1b7355-4802-d277-e063-6394a90aef44"], "manufacturer_name": ["RedPharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE (67296-2114-2)", "package_ndc": "67296-2114-2", "marketing_start_date": "20210527"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (67296-2114-6)", "package_ndc": "67296-2114-6", "marketing_start_date": "20210527"}], "brand_name": "Labetalol Hydrochloride", "product_id": "67296-2114_3b0aa187-8058-8e3b-e063-6294a90a373e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "67296-2114", "generic_name": "Labetalol Hydrochloride", "labeler_name": "RedPharm Drug", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA209603", "marketing_category": "ANDA", "marketing_start_date": "20210527", "listing_expiration_date": "20261231"}