valproate sodium

Generic: valproate sodium

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valproate sodium
Generic Name valproate sodium
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

valproate sodium 100 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-797
Product ID 25021-797_bac93779-c94f-49e9-90b7-5a53739b47be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076295
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

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 25021797
Hyphenated Format 25021-797

Supplemental Identifiers

RxCUI
1099648
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 ANDA076295 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-797-05) / 5 mL in 1 VIAL
source: ndc

Packages (1)

Ingredients (1)

valproate sodium (100 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "bac93779-c94f-49e9-90b7-5a53739b47be", "openfda": {"unii": ["5VOM6GYJ0D"], "rxcui": ["1099648"], "spl_set_id": ["8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-797-05)  / 5 mL in 1 VIAL", "package_ndc": "25021-797-05", "marketing_start_date": "20241201"}], "brand_name": "Valproate Sodium", "product_id": "25021-797_bac93779-c94f-49e9-90b7-5a53739b47be", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "25021-797", "generic_name": "Valproate Sodium", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valproate Sodium", "active_ingredients": [{"name": "VALPROATE SODIUM", "strength": "100 mg/mL"}], "application_number": "ANDA076295", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}