labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hydrochloride
Generic Name labetalol hydrochloride
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

labetalol hydrochloride 5 mg/mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 36000-324
Product ID 36000-324_219d4dec-02d1-4d4b-88fd-01b1dbad3abc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076051
Listing Expiration 2026-12-31
Marketing Start 2021-01-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36000324
Hyphenated Format 36000-324

Supplemental Identifiers

RxCUI
896771 2477889
UPC
0336000324014 0336000320016 0336000322010
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 ANDA076051 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (36000-324-02) / 40 mL in 1 VIAL (36000-324-01)
source: ndc

Packages (1)

36000-324-02 1 VIAL in 1 CARTON (36000-324-02) / 40 mL in 1 VIAL (36000-324-01)

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": "219d4dec-02d1-4d4b-88fd-01b1dbad3abc", "openfda": {"upc": ["0336000324014", "0336000320016", "0336000322010"], "unii": ["1GEV3BAW9J"], "rxcui": ["896771", "2477889"], "spl_set_id": ["b17a7b3a-e7a5-4987-ae85-ad970e7540c7"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (36000-324-02)  / 40 mL in 1 VIAL (36000-324-01)", "package_ndc": "36000-324-02", "marketing_start_date": "20210126"}], "brand_name": "Labetalol Hydrochloride", "product_id": "36000-324_219d4dec-02d1-4d4b-88fd-01b1dbad3abc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "36000-324", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA076051", "marketing_category": "ANDA", "marketing_start_date": "20210126", "listing_expiration_date": "20261231"}