labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler northstar rx llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 5 mg/mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-146
Product ID 72603-146_a2d07ec0-3718-40eb-9d0a-79c557c486b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214533
Listing Expiration 2026-12-31
Marketing Start 2023-04-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603146
Hyphenated Format 72603-146

Supplemental Identifiers

RxCUI
896771
UPC
0372603146011
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, MULTI-DOSE in 1 CARTON (72603-146-01) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

72603-146-01 1 VIAL, MULTI-DOSE in 1 CARTON (72603-146-01) / 20 mL in 1 VIAL, MULTI-DOSE

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": "a2d07ec0-3718-40eb-9d0a-79c557c486b9", "openfda": {"upc": ["0372603146011"], "unii": ["1GEV3BAW9J"], "rxcui": ["896771"], "spl_set_id": ["a2d07ec0-3718-40eb-9d0a-79c557c486b9"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (72603-146-01)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "72603-146-01", "marketing_start_date": "20230428"}], "brand_name": "Labetalol Hydrochloride", "product_id": "72603-146_a2d07ec0-3718-40eb-9d0a-79c557c486b9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72603-146", "generic_name": "Labetalol Hydrochloride", "labeler_name": "NorthStar Rx LLC", "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": "20230428", "listing_expiration_date": "20261231"}