labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 5 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-0125
Product ID 0409-0125_c1772ea4-65eb-4f27-8e33-3de06278acfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075240
Listing Expiration 2026-12-31
Marketing Start 2023-08-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04090125
Hyphenated Format 0409-0125

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 ANDA075240 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01)
source: ndc

Packages (1)

0409-0125-25 25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01)

Ingredients (1)

labetalol hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Labetalol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c1772ea4-65eb-4f27-8e33-3de06278acfe", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896771"], "spl_set_id": ["abfc6b75-1ed5-41f1-0484-4597488237bc"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25)  / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01)", "package_ndc": "0409-0125-25", "marketing_start_date": "20230807"}], "brand_name": "Labetalol Hydrochloride", "product_id": "0409-0125_c1772ea4-65eb-4f27-8e33-3de06278acfe", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0409-0125", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA075240", "marketing_category": "ANDA", "marketing_start_date": "20230807", "listing_expiration_date": "20261231"}