labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: fosun pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler fosun pharma usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 5 mg/mL

Manufacturer
Fosun Pharma USA Inc.

Identifiers & Regulatory

Product NDC 72266-103
Product ID 72266-103_2b363395-43e6-3aee-e063-6294a90a4e89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090699
Listing Expiration 2026-12-31
Marketing Start 2021-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72266103
Hyphenated Format 72266-103

Supplemental Identifiers

RxCUI
896771
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
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (72266-103-41) / 40 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

72266-103-41 1 VIAL, MULTI-DOSE in 1 CARTON (72266-103-41) / 40 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

labetalol hydrochloride (5 mg/mL)

Linked Drug Pages (2)

Labetalol Hydrochloride ndc-match (0.9) Labetalol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2b363395-43e6-3aee-e063-6294a90a4e89", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896771"], "spl_set_id": ["f18dff28-f6f5-4ecb-9797-25062e247559"], "manufacturer_name": ["Fosun Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (72266-103-41)  / 40 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "72266-103-41", "marketing_start_date": "20210331"}], "brand_name": "Labetalol Hydrochloride", "product_id": "72266-103_2b363395-43e6-3aee-e063-6294a90a4e89", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72266-103", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Fosun Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA090699", "marketing_category": "ANDA", "marketing_start_date": "20210331", "listing_expiration_date": "20261231"}