divalproex sodium

Generic: divalproex sodium

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

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

divalproex sodium 125 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-106
Product ID 68382-106_f6d3709a-e6b8-442f-84ea-be51e7e26a9f
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 68382106
Hyphenated Format 68382-106

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 (68382-106-01)
  • 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-106-10)
  • 100 BLISTER PACK in 1 CARTON (68382-106-77) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-106-30)
source: ndc

Packages (3)

68382-106-01 100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-106-01) 68382-106-10 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-106-10) 68382-106-77 100 BLISTER PACK in 1 CARTON (68382-106-77) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-106-30)

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": "f6d3709a-e6b8-442f-84ea-be51e7e26a9f", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099596"], "spl_set_id": ["ed710c62-8ba6-4f19-b240-3ee73cd03d67"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-106-01)", "package_ndc": "68382-106-01", "marketing_start_date": "20090127"}, {"sample": false, "description": "1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-106-10)", "package_ndc": "68382-106-10", "marketing_start_date": "20090127"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (68382-106-77)  / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-106-30)", "package_ndc": "68382-106-77", "marketing_start_date": "20090127"}], "brand_name": "divalproex sodium", "product_id": "68382-106_f6d3709a-e6b8-442f-84ea-be51e7e26a9f", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "68382-106", "generic_name": "divalproex sodium", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "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"}