labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

labetalol hydrochloride 300 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-800
Product ID 62135-800_44fde4f9-0088-6476-e063-6394a90a6a92
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 62135800
Hyphenated Format 62135-800

Supplemental Identifiers

RxCUI
896758 896762 896766
UPC
0362135791605 0362135800604 0362135792602
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
  • 300 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (62135-800-60)
source: ndc

Packages (1)

62135-800-60 60 TABLET in 1 BOTTLE (62135-800-60)

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": "44fde4f9-0088-6476-e063-6394a90a6a92", "openfda": {"upc": ["0362135791605", "0362135800604", "0362135792602"], "unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["ac439c08-1e47-4306-8308-b31d7a1a443c"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (62135-800-60)", "package_ndc": "62135-800-60", "marketing_start_date": "20231024"}], "brand_name": "Labetalol Hydrochloride", "product_id": "62135-800_44fde4f9-0088-6476-e063-6394a90a6a92", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "62135-800", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA074787", "marketing_category": "ANDA", "marketing_start_date": "20200222", "listing_expiration_date": "20261231"}