labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 300 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-461
Product ID 60687-461_2a7ffcfa-7d3f-473c-e063-6394a90ad673
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207743
Listing Expiration 2026-12-31
Marketing Start 2019-07-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687461
Hyphenated Format 60687-461

Supplemental Identifiers

RxCUI
896758 896762 896766
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 ANDA207743 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-461-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-461-11)
source: ndc

Packages (1)

60687-461-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-461-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-461-11)

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": "2a7ffcfa-7d3f-473c-e063-6394a90ad673", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["3004aa59-288c-4971-b77b-78789715ef5a"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-461-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-461-11)", "package_ndc": "60687-461-01", "marketing_start_date": "20190716"}], "brand_name": "Labetalol Hydrochloride", "product_id": "60687-461_2a7ffcfa-7d3f-473c-e063-6394a90ad673", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "60687-461", "generic_name": "Labetalol Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA207743", "marketing_category": "ANDA", "marketing_start_date": "20190716", "listing_expiration_date": "20261231"}