labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

labetalol hydrochloride 100 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-723
Product ID 23155-723_3c7a32b9-aa02-4418-a019-448f560692ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074787
Listing Expiration 2026-12-31
Marketing Start 2020-02-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155723
Hyphenated Format 23155-723

Supplemental Identifiers

RxCUI
896758 896762 896766
UPC
0323155725018 0323155724011 0323155723014
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 ANDA074787 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (23155-723-01)
  • 500 TABLET in 1 BOTTLE (23155-723-05)
source: ndc

Packages (2)

23155-723-01 100 TABLET in 1 BOTTLE (23155-723-01) 23155-723-05 500 TABLET in 1 BOTTLE (23155-723-05)

Ingredients (1)

labetalol hydrochloride (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": "3c7a32b9-aa02-4418-a019-448f560692ad", "openfda": {"upc": ["0323155725018", "0323155724011", "0323155723014"], "unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["bf84ebae-3c91-4448-b1db-8e5ed3053866"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (23155-723-01)", "package_ndc": "23155-723-01", "marketing_start_date": "20200222"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (23155-723-05)", "package_ndc": "23155-723-05", "marketing_start_date": "20200222"}], "brand_name": "Labetalol Hydrochloride", "product_id": "23155-723_3c7a32b9-aa02-4418-a019-448f560692ad", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "23155-723", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA074787", "marketing_category": "ANDA", "marketing_start_date": "20200222", "listing_expiration_date": "20261231"}