divalproex sodium

Generic: divalproex sodium

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 125 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-821
Product ID 46708-821_f34c4504-5409-406e-995b-138e5f700242
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218793
Listing Expiration 2026-12-31
Marketing Start 2024-12-23

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 46708821
Hyphenated Format 46708-821

Supplemental Identifiers

RxCUI
1099596
UPC
0346708821319
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 ANDA218793 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (46708-821-10) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-31)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-91)
source: ndc

Packages (3)

46708-821-10 100 BLISTER PACK in 1 CARTON (46708-821-10) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK 46708-821-31 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-31) 46708-821-91 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-91)

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": "f34c4504-5409-406e-995b-138e5f700242", "openfda": {"upc": ["0346708821319"], "unii": ["644VL95AO6"], "rxcui": ["1099596"], "spl_set_id": ["f34c4504-5409-406e-995b-138e5f700242"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (46708-821-10)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "46708-821-10", "marketing_start_date": "20241223"}, {"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-31)", "package_ndc": "46708-821-31", "marketing_start_date": "20241223"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-91)", "package_ndc": "46708-821-91", "marketing_start_date": "20241223"}], "brand_name": "Divalproex sodium", "product_id": "46708-821_f34c4504-5409-406e-995b-138e5f700242", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "46708-821", "generic_name": "Divalproex sodium", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "125 mg/1"}], "application_number": "ANDA218793", "marketing_category": "ANDA", "marketing_start_date": "20241223", "listing_expiration_date": "20261231"}