valproate sodium

Generic: valproate sodium

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

Drug Facts

Product Profile

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

valproate sodium 100 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-494
Product ID 63323-494_f09a2148-edd9-4918-8359-7554ed263d3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076539
Listing Expiration 2026-12-31
Marketing Start 2003-08-18

Pharmacologic Class

Classes
anti-epileptic agent [epc] decreased central nervous system disorganized electrical activity [pe] mood stabilizer [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323494
Hyphenated Format 63323-494

Supplemental Identifiers

RxCUI
1099648
UPC
0363323494414
UNII
5VOM6GYJ0D

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 valproate sodium (source: ndc)
Generic Name valproate sodium (source: ndc)
Application Number ANDA076539 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-16) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-41)
source: ndc

Packages (1)

63323-494-16 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-16) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-41)

Ingredients (1)

valproate sodium (100 mg/mL)

Linked Drug Pages (2)

Valproate Sodium ndc-match (0.9) Valproate Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f09a2148-edd9-4918-8359-7554ed263d3a", "openfda": {"upc": ["0363323494414"], "unii": ["5VOM6GYJ0D"], "rxcui": ["1099648"], "spl_set_id": ["3dfb6da1-f66a-4618-9f74-d2d6c16c0b58"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-16)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-41)", "package_ndc": "63323-494-16", "marketing_start_date": "20030818"}], "brand_name": "Valproate Sodium", "product_id": "63323-494_f09a2148-edd9-4918-8359-7554ed263d3a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "63323-494", "generic_name": "VALPROATE SODIUM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valproate Sodium", "active_ingredients": [{"name": "VALPROATE SODIUM", "strength": "100 mg/mL"}], "application_number": "ANDA076539", "marketing_category": "ANDA", "marketing_start_date": "20030818", "listing_expiration_date": "20261231"}