labetalol hydrochloride

Generic: labetalol hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

labetalol hydrochloride 5 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-111
Product ID 68083-111_f3cca933-34c3-4efd-81c6-02a4920dda16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090699
Listing Expiration 2026-12-31
Marketing Start 2012-04-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083111
Hyphenated Format 68083-111

Supplemental Identifiers

RxCUI
896771
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 ANDA090699 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (68083-111-01) / 20 mL in 1 VIAL, GLASS
  • 10 VIAL, GLASS in 1 CARTON (68083-111-02) / 40 mL in 1 VIAL, GLASS
source: ndc

Packages (2)

68083-111-01 10 VIAL, GLASS in 1 CARTON (68083-111-01) / 20 mL in 1 VIAL, GLASS 68083-111-02 10 VIAL, GLASS in 1 CARTON (68083-111-02) / 40 mL in 1 VIAL, GLASS

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": "f3cca933-34c3-4efd-81c6-02a4920dda16", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896771"], "spl_set_id": ["48caf986-3126-48e1-afcd-16d65c9cfe00"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (68083-111-01)  / 20 mL in 1 VIAL, GLASS", "package_ndc": "68083-111-01", "marketing_start_date": "20120419"}, {"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (68083-111-02)  / 40 mL in 1 VIAL, GLASS", "package_ndc": "68083-111-02", "marketing_start_date": "20120419"}], "brand_name": "Labetalol Hydrochloride", "product_id": "68083-111_f3cca933-34c3-4efd-81c6-02a4920dda16", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68083-111", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA090699", "marketing_category": "ANDA", "marketing_start_date": "20120419", "listing_expiration_date": "20261231"}