valproic acid

Generic: valproic acid

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valproic acid
Generic Name valproic acid
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

valproic acid 250 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-196
Product ID 62135-196_19ae228a-30e6-9bd6-e063-6294a90a526d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075782
Listing Expiration 2026-12-31
Marketing Start 2000-12-22

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 62135196
Hyphenated Format 62135-196

Supplemental Identifiers

RxCUI
1099687
UPC
0362135196479
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 ANDA075782 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-196-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-196-45)
  • 473 mL in 1 BOTTLE (62135-196-47)
source: ndc

Packages (2)

62135-196-24 2 TRAY in 1 BOX (62135-196-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-196-45) 62135-196-47 473 mL in 1 BOTTLE (62135-196-47)

Ingredients (1)

valproic acid (250 mg/5mL)

Linked Drug Pages (1)

Valproic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "19ae228a-30e6-9bd6-e063-6294a90a526d", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751"], "upc": ["0362135196479"], "unii": ["614OI1Z5WI"], "rxcui": ["1099687"], "spl_set_id": ["8051ad62-3b6e-461e-8090-60f5c0a904f4"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-196-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-196-45)", "package_ndc": "62135-196-24", "marketing_start_date": "20240528"}, {"sample": false, "description": "473 mL in 1 BOTTLE (62135-196-47)", "package_ndc": "62135-196-47", "marketing_start_date": "20220815"}], "brand_name": "Valproic Acid", "product_id": "62135-196_19ae228a-30e6-9bd6-e063-6294a90a526d", "dosage_form": "SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "62135-196", "generic_name": "Valproic Acid", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valproic Acid", "active_ingredients": [{"name": "VALPROIC ACID", "strength": "250 mg/5mL"}], "application_number": "ANDA075782", "marketing_category": "ANDA", "marketing_start_date": "20001222", "listing_expiration_date": "20261231"}