valproate sodium

Generic: valproate sodium

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valproate sodium
Generic Name valproate sodium
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

valproate sodium 100 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9637
Product ID 0143-9637_4b1e2230-e7d4-470f-9ec5-99d03e80e897
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078523
Listing Expiration 2026-12-31
Marketing Start 2013-04-15

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 01439637
Hyphenated Format 0143-9637

Supplemental Identifiers

RxCUI
1099648
UPC
0301439637103
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 ANDA078523 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 TRAY (0143-9637-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9637-01)
source: ndc

Packages (1)

0143-9637-10 10 VIAL, SINGLE-DOSE in 1 TRAY (0143-9637-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9637-01)

Ingredients (1)

valproate sodium (100 mg/mL)

Linked Drug Pages (1)

Valproate Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4b1e2230-e7d4-470f-9ec5-99d03e80e897", "openfda": {"upc": ["0301439637103"], "unii": ["5VOM6GYJ0D"], "rxcui": ["1099648"], "spl_set_id": ["7a687b2f-246d-4736-a20c-92421c263268"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 TRAY (0143-9637-10)  / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9637-01)", "package_ndc": "0143-9637-10", "marketing_start_date": "20130415"}], "brand_name": "Valproate Sodium", "product_id": "0143-9637_4b1e2230-e7d4-470f-9ec5-99d03e80e897", "dosage_form": "INJECTION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "0143-9637", "generic_name": "Valproate Sodium", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valproate Sodium", "active_ingredients": [{"name": "VALPROATE SODIUM", "strength": "100 mg/mL"}], "application_number": "ANDA078523", "marketing_category": "ANDA", "marketing_start_date": "20130415", "listing_expiration_date": "20261231"}