labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 100 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-798
Product ID 68382-798_49639538-dfdd-4312-9664-701e8bdbe191
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207743
Listing Expiration 2027-12-31
Marketing Start 2017-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382798
Hyphenated Format 68382-798

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68382-798-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (68382-798-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68382-798-06)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68382-798-16)
source: ndc

Packages (4)

68382-798-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-798-01) 68382-798-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-798-05) 68382-798-06 30 TABLET, FILM COATED in 1 BOTTLE (68382-798-06) 68382-798-16 90 TABLET, FILM COATED in 1 BOTTLE (68382-798-16)

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": "49639538-dfdd-4312-9664-701e8bdbe191", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["5942a5a8-c3c1-4ecb-921e-9bc92393bdf8"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-798-01)", "package_ndc": "68382-798-01", "marketing_start_date": "20171205"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-798-05)", "package_ndc": "68382-798-05", "marketing_start_date": "20171205"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68382-798-06)", "package_ndc": "68382-798-06", "marketing_start_date": "20171205"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-798-16)", "package_ndc": "68382-798-16", "marketing_start_date": "20171205"}], "brand_name": "Labetalol Hydrochloride", "product_id": "68382-798_49639538-dfdd-4312-9664-701e8bdbe191", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68382-798", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA207743", "marketing_category": "ANDA", "marketing_start_date": "20171205", "listing_expiration_date": "20271231"}