divalproex sodium

Generic: divalproex sodium

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler zydus lifesciences limited
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

divalproex sodium 125 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-639
Product ID 65841-639_9b43fd1a-165d-420e-ba4f-f7bfaea4c283
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078919
Listing Expiration 2026-12-31
Marketing Start 2009-01-27

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 65841639
Hyphenated Format 65841-639

Supplemental Identifiers

RxCUI
1099596
UNII
644VL95AO6

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 divalproex sodium (source: ndc)
Generic Name divalproex sodium (source: ndc)
Application Number ANDA078919 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 100 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-01)
  • 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-10)
  • 10 BLISTER PACK in 1 CARTON (65841-639-30) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK
source: ndc

Packages (3)

65841-639-01 100 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-01) 65841-639-10 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-10) 65841-639-30 10 BLISTER PACK in 1 CARTON (65841-639-30) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK

Ingredients (1)

divalproex sodium (125 mg/1)

Linked Drug Pages (1)

divalproex sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9b43fd1a-165d-420e-ba4f-f7bfaea4c283", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099596"], "spl_set_id": ["b0f33792-dd96-40cc-a28e-acdcdca2f4b8"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-01)", "package_ndc": "65841-639-01", "marketing_start_date": "20090127"}, {"sample": false, "description": "1000 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-10)", "package_ndc": "65841-639-10", "marketing_start_date": "20090127"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65841-639-30)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK", "package_ndc": "65841-639-30", "marketing_start_date": "20090127"}], "brand_name": "divalproex sodium", "product_id": "65841-639_9b43fd1a-165d-420e-ba4f-f7bfaea4c283", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "65841-639", "generic_name": "divalproex sodium", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "divalproex sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "125 mg/1"}], "application_number": "ANDA078919", "marketing_category": "ANDA", "marketing_start_date": "20090127", "listing_expiration_date": "20261231"}