labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: mullan pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler mullan pharmaceutical inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 100 mg/20mL

Manufacturer
Mullan Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 83301-0058
Product ID 83301-0058_e49bc25a-e39e-469a-8372-bd28e2b1ca7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090699
Listing Expiration 2026-12-31
Marketing Start 2025-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 833010058
Hyphenated Format 83301-0058

Supplemental Identifiers

RxCUI
896771
UPC
0383301005814
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 ANDA090699 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (83301-0058-1) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

83301-0058-1 1 VIAL, MULTI-DOSE in 1 CARTON (83301-0058-1) / 20 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

labetalol hydrochloride (100 mg/20mL)

Linked Drug Pages (1)

Labetalol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e49bc25a-e39e-469a-8372-bd28e2b1ca7f", "openfda": {"upc": ["0383301005814"], "unii": ["1GEV3BAW9J"], "rxcui": ["896771"], "spl_set_id": ["fb5ef3ba-0a7e-4f41-9547-d734983da0d3"], "manufacturer_name": ["Mullan Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (83301-0058-1)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "83301-0058-1", "marketing_start_date": "20251205"}], "brand_name": "Labetalol Hydrochloride", "product_id": "83301-0058_e49bc25a-e39e-469a-8372-bd28e2b1ca7f", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "83301-0058", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Mullan Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "100 mg/20mL"}], "application_number": "ANDA090699", "marketing_category": "ANDA", "marketing_start_date": "20251205", "listing_expiration_date": "20261231"}