labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler caplin steriles limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 5 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-125
Product ID 65145-125_24f8e54c-549c-41c6-aed6-f4036dd6f11f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214533
Listing Expiration 2026-12-31
Marketing Start 2025-02-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145125
Hyphenated Format 65145-125

Supplemental Identifiers

RxCUI
896771
UPC
0365145124012 0365145125019
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 (65145-125-01) / 40 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

65145-125-01 1 VIAL, MULTI-DOSE in 1 CARTON (65145-125-01) / 40 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": "24f8e54c-549c-41c6-aed6-f4036dd6f11f", "openfda": {"upc": ["0365145124012", "0365145125019"], "unii": ["1GEV3BAW9J"], "rxcui": ["896771"], "spl_set_id": ["77152699-1ca8-442a-8cb4-80b0ffbec6f2"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (65145-125-01)  / 40 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "65145-125-01", "marketing_start_date": "20250214"}], "brand_name": "Labetalol Hydrochloride", "product_id": "65145-125_24f8e54c-549c-41c6-aed6-f4036dd6f11f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "65145-125", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Caplin Steriles Limited", "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": "20250214", "listing_expiration_date": "20261231"}