divalproex sodium

Generic: divalproex sodium

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler american health packaging
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 500 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-415
Product ID 68084-415_46405f96-5e81-a0c9-e063-6394a90a9592
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078239
Marketing Start 2013-11-21
Marketing End 2026-11-30

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 68084415
Hyphenated Format 68084-415

Supplemental Identifiers

RxCUI
1099563 1099569
UNII
644VL95AO6

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 ANDA078239 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-415-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-415-11)
  • 80 BLISTER PACK in 1 CARTON (68084-415-02) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-415-93)
source: ndc

Packages (2)

68084-415-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-415-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-415-11) 68084-415-02 80 BLISTER PACK in 1 CARTON (68084-415-02) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-415-93)

Ingredients (1)

divalproex sodium (500 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": "46405f96-5e81-a0c9-e063-6394a90a9592", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099563", "1099569"], "spl_set_id": ["a8ba3986-1ded-44a8-8d10-d0f252a07794"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-415-01)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-415-11)", "package_ndc": "68084-415-01", "marketing_end_date": "20261130", "marketing_start_date": "20131121"}, {"sample": false, "description": "80 BLISTER PACK in 1 CARTON (68084-415-02)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-415-93)", "package_ndc": "68084-415-02", "marketing_end_date": "20260630", "marketing_start_date": "20230206"}], "brand_name": "Divalproex Sodium", "product_id": "68084-415_46405f96-5e81-a0c9-e063-6394a90a9592", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "68084-415", "generic_name": "Divalproex Sodium", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex Sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA078239", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20131121"}