valproic acid

Generic: valproic acid

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valproic acid
Generic Name valproic acid
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

valproic acid 250 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-085
Product ID 43353-085_a83d04b7-84f7-4967-9721-a82a0fe8d83e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073229
Listing Expiration 2026-12-31
Marketing Start 2011-10-29

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 43353085
Hyphenated Format 43353-085

Supplemental Identifiers

RxCUI
1099681
UNII
614OI1Z5WI
NUI
N0000175753 N0000008486 N0000175751

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 ANDA073229 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (43353-085-53)
  • 90 CAPSULE in 1 BOTTLE (43353-085-60)
  • 120 CAPSULE in 1 BOTTLE (43353-085-70)
  • 180 CAPSULE in 1 BOTTLE (43353-085-80)
  • 240 CAPSULE in 1 BOTTLE (43353-085-90)
  • 360 CAPSULE in 1 BOTTLE (43353-085-94)
source: ndc

Packages (6)

43353-085-53 60 CAPSULE in 1 BOTTLE (43353-085-53) 43353-085-60 90 CAPSULE in 1 BOTTLE (43353-085-60) 43353-085-70 120 CAPSULE in 1 BOTTLE (43353-085-70) 43353-085-80 180 CAPSULE in 1 BOTTLE (43353-085-80) 43353-085-90 240 CAPSULE in 1 BOTTLE (43353-085-90) 43353-085-94 360 CAPSULE in 1 BOTTLE (43353-085-94)

Ingredients (1)

valproic acid (250 mg/1)

Linked Drug Pages (1)

valproic acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a83d04b7-84f7-4967-9721-a82a0fe8d83e", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751"], "unii": ["614OI1Z5WI"], "rxcui": ["1099681"], "spl_set_id": ["3904177b-8a26-4356-9080-d2a2e3f468af"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (43353-085-53)", "package_ndc": "43353-085-53", "marketing_start_date": "20150720"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (43353-085-60)", "package_ndc": "43353-085-60", "marketing_start_date": "20150720"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (43353-085-70)", "package_ndc": "43353-085-70", "marketing_start_date": "20151216"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (43353-085-80)", "package_ndc": "43353-085-80", "marketing_start_date": "20151215"}, {"sample": false, "description": "240 CAPSULE in 1 BOTTLE (43353-085-90)", "package_ndc": "43353-085-90", "marketing_start_date": "20160523"}, {"sample": false, "description": "360 CAPSULE in 1 BOTTLE (43353-085-94)", "package_ndc": "43353-085-94", "marketing_start_date": "20151028"}], "brand_name": "valproic acid", "product_id": "43353-085_a83d04b7-84f7-4967-9721-a82a0fe8d83e", "dosage_form": "CAPSULE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "43353-085", "generic_name": "valproic acid", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "valproic acid", "active_ingredients": [{"name": "VALPROIC ACID", "strength": "250 mg/1"}], "application_number": "ANDA073229", "marketing_category": "ANDA", "marketing_start_date": "20111029", "listing_expiration_date": "20261231"}