labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 5 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-317
Product ID 25021-317_02cc0ab9-5ab4-4016-9ec2-b96c4cb2be41
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214533
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021317
Hyphenated Format 25021-317

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 ANDA214533 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-317-20) / 20 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (25021-317-40) / 40 mL in 1 VIAL
source: ndc

Packages (2)

25021-317-20 1 VIAL in 1 CARTON (25021-317-20) / 20 mL in 1 VIAL 25021-317-40 1 VIAL in 1 CARTON (25021-317-40) / 40 mL in 1 VIAL

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": "02cc0ab9-5ab4-4016-9ec2-b96c4cb2be41", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896771"], "spl_set_id": ["da8af6c2-d822-4ae5-9c2d-a1d161bdefd0"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-317-20)  / 20 mL in 1 VIAL", "package_ndc": "25021-317-20", "marketing_start_date": "20220901"}, {"sample": false, "description": "1 VIAL in 1 CARTON (25021-317-40)  / 40 mL in 1 VIAL", "package_ndc": "25021-317-40", "marketing_start_date": "20220901"}], "brand_name": "labetalol hydrochloride", "product_id": "25021-317_02cc0ab9-5ab4-4016-9ec2-b96c4cb2be41", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "25021-317", "generic_name": "labetalol hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "labetalol hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA214533", "marketing_category": "ANDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}