labetalol hcl

Generic: labetalol hcl

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hcl
Generic Name labetalol hcl
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 5 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1602
Product ID 51662-1602_ea035948-1a97-5d6e-e053-2995a90a3e7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075303
Listing Expiration 2026-12-31
Marketing Start 2022-08-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621602
Hyphenated Format 51662-1602

Supplemental Identifiers

RxCUI
896771
UNII
1GEV3BAW9J

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 hcl (source: ndc)
Generic Name labetalol hcl (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 (51662-1602-1) / 20 mL in 1 VIAL
  • 20 mL in 1 VIAL (51662-1602-9)
source: ndc

Packages (2)

51662-1602-1 1 VIAL in 1 BOX, UNIT-DOSE (51662-1602-1) / 20 mL in 1 VIAL 51662-1602-9 20 mL in 1 VIAL (51662-1602-9)

Ingredients (1)

labetalol hydrochloride (5 mg/mL)

Linked Drug Pages (1)

LABETALOL HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ea035948-1a97-5d6e-e053-2995a90a3e7b", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896771"], "spl_set_id": ["e76c4b37-4a34-249d-e053-2995a90aa9be"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX, UNIT-DOSE (51662-1602-1)  / 20 mL in 1 VIAL", "package_ndc": "51662-1602-1", "marketing_start_date": "20220829"}, {"sample": false, "description": "20 mL in 1 VIAL (51662-1602-9)", "package_ndc": "51662-1602-9", "marketing_start_date": "20221001"}], "brand_name": "LABETALOL HCl", "product_id": "51662-1602_ea035948-1a97-5d6e-e053-2995a90a3e7b", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "51662-1602", "generic_name": "LABETALOL HCl", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LABETALOL HCl", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA075303", "marketing_category": "ANDA", "marketing_start_date": "20220829", "listing_expiration_date": "20261231"}