labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler cadila pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 300 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-085
Product ID 71209-085_72d9c230-fb71-4b4b-a4d2-01bf96153ec2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211325
Listing Expiration 2026-12-31
Marketing Start 2018-03-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71209085
Hyphenated Format 71209-085

Supplemental Identifiers

RxCUI
896758 896762 896766
UPC
0371209084109 0371209083102 0371209083058
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 ANDA211325 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (71209-085-03)
  • 100 TABLET, FILM COATED in 1 BOTTLE (71209-085-05)
  • 500 TABLET, FILM COATED in 1 BOTTLE (71209-085-10)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (71209-085-11)
source: ndc

Packages (4)

71209-085-03 60 TABLET, FILM COATED in 1 BOTTLE (71209-085-03) 71209-085-05 100 TABLET, FILM COATED in 1 BOTTLE (71209-085-05) 71209-085-10 500 TABLET, FILM COATED in 1 BOTTLE (71209-085-10) 71209-085-11 1000 TABLET, FILM COATED in 1 BOTTLE (71209-085-11)

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": "72d9c230-fb71-4b4b-a4d2-01bf96153ec2", "openfda": {"upc": ["0371209084109", "0371209083102", "0371209083058"], "unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["5fba93fc-4580-48c2-a1ec-5d446680adcf"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71209-085-03)", "package_ndc": "71209-085-03", "marketing_start_date": "20180630"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71209-085-05)", "package_ndc": "71209-085-05", "marketing_start_date": "20221124"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (71209-085-10)", "package_ndc": "71209-085-10", "marketing_start_date": "20221124"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (71209-085-11)", "package_ndc": "71209-085-11", "marketing_start_date": "20180630"}], "brand_name": "Labetalol Hydrochloride", "product_id": "71209-085_72d9c230-fb71-4b4b-a4d2-01bf96153ec2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "71209-085", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA211325", "marketing_category": "ANDA", "marketing_start_date": "20180305", "listing_expiration_date": "20261231"}