valproic acid

Generic: valproic acid

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valproic acid
Generic Name valproic acid
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

valproic acid 500 mg/10mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1350
Product ID 0121-1350_8c4404f6-81d2-4211-b6b9-5e8d1f497dd6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075379
Listing Expiration 2026-12-31
Marketing Start 2005-04-11

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc] mood stabilizer [epc]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01211350
Hyphenated Format 0121-1350

Supplemental Identifiers

RxCUI
1099687
UNII
614OI1Z5WI
NUI
N0000175753 N0000008486 N0000175751

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 valproic acid (source: ndc)
Generic Name valproic acid (source: ndc)
Application Number ANDA075379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-1350-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1350-10)
source: ndc

Packages (1)

0121-1350-00 10 TRAY in 1 CASE (0121-1350-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1350-10)

Ingredients (1)

valproic acid (500 mg/10mL)

Linked Drug Pages (1)

VALPROIC ACID ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8c4404f6-81d2-4211-b6b9-5e8d1f497dd6", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751"], "unii": ["614OI1Z5WI"], "rxcui": ["1099687"], "spl_set_id": ["7d5cb52e-37dd-4dfa-a6f4-09f9548846c6"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-1350-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1350-10)", "package_ndc": "0121-1350-00", "marketing_start_date": "20050411"}], "brand_name": "VALPROIC ACID", "product_id": "0121-1350_8c4404f6-81d2-4211-b6b9-5e8d1f497dd6", "dosage_form": "SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "0121-1350", "generic_name": "VALPROIC ACID", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VALPROIC ACID", "active_ingredients": [{"name": "VALPROIC ACID", "strength": "500 mg/10mL"}], "application_number": "ANDA075379", "marketing_category": "ANDA", "marketing_start_date": "20050411", "listing_expiration_date": "20261231"}