labetalol hydrochloride

Generic: labetalol hydrochloride

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

Drug Facts

Product Profile

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

labetalol hydrochloride 5 mg/mL

Manufacturer
Civica, Inc.

Identifiers & Regulatory

Product NDC 72572-350
Product ID 72572-350_076e0f01-e1cb-4948-9d90-865ff7d4a47c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075303
Listing Expiration 2026-12-31
Marketing Start 2019-11-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72572350
Hyphenated Format 72572-350

Supplemental Identifiers

RxCUI
896771
UPC
0372572350013
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 ANDA075303 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX, UNIT-DOSE (72572-350-01) / 20 mL in 1 VIAL
source: ndc

Packages (1)

72572-350-01 1 VIAL in 1 BOX, UNIT-DOSE (72572-350-01) / 20 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": "076e0f01-e1cb-4948-9d90-865ff7d4a47c", "openfda": {"upc": ["0372572350013"], "unii": ["1GEV3BAW9J"], "rxcui": ["896771"], "spl_set_id": ["d7c53b1c-b6a5-482a-a7c8-7425d9cd9ef8"], "manufacturer_name": ["Civica, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX, UNIT-DOSE (72572-350-01)  / 20 mL in 1 VIAL", "package_ndc": "72572-350-01", "marketing_start_date": "20191121"}], "brand_name": "Labetalol Hydrochloride", "product_id": "72572-350_076e0f01-e1cb-4948-9d90-865ff7d4a47c", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72572-350", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Civica, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA075303", "marketing_category": "ANDA", "marketing_start_date": "20191121", "listing_expiration_date": "20261231"}