esmolol hydrochloride

Generic: esmolol hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esmolol hydrochloride
Generic Name esmolol hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

esmolol hydrochloride 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-652
Product ID 63323-652_961c04d5-1f12-4095-a4b9-1842574f7f97
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076573
Listing Expiration 2026-12-31
Marketing Start 2004-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323652
Hyphenated Format 63323-652

Supplemental Identifiers

RxCUI
1736546
UPC
0363323661045 0363323652012
UNII
V05260LC8D

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 esmolol hydrochloride (source: ndc)
Generic Name esmolol hydrochloride (source: ndc)
Application Number ANDA076573 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-652-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-652-01)
source: ndc

Packages (1)

63323-652-10 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-652-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-652-01)

Ingredients (1)

esmolol hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Esmolol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "961c04d5-1f12-4095-a4b9-1842574f7f97", "openfda": {"upc": ["0363323661045", "0363323652012"], "unii": ["V05260LC8D"], "rxcui": ["1736546"], "spl_set_id": ["fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-652-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-652-01)", "package_ndc": "63323-652-10", "marketing_start_date": "20041130"}], "brand_name": "Esmolol Hydrochloride", "product_id": "63323-652_961c04d5-1f12-4095-a4b9-1842574f7f97", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "63323-652", "generic_name": "ESMOLOL HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esmolol Hydrochloride", "active_ingredients": [{"name": "ESMOLOL HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA076573", "marketing_category": "ANDA", "marketing_start_date": "20041130", "listing_expiration_date": "20261231"}