divalproex sodium

Generic: divalproex sodium

Labeler: dr. reddy's laboratories ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler dr. reddy's laboratories ltd
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 250 mg/1

Manufacturer
Dr. Reddy's Laboratories Ltd

Identifiers & Regulatory

Product NDC 55111-533
Product ID 55111-533_bbff7587-1b4e-6616-e6f5-689bc89e1aea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090161
Listing Expiration 2026-12-31
Marketing Start 2013-08-11

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 55111533
Hyphenated Format 55111-533

Supplemental Identifiers

RxCUI
1099563
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 ANDA090161 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-60)
  • 10 BLISTER PACK in 1 CARTON (55111-533-78) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-533-79)
source: ndc

Packages (5)

55111-533-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-01) 55111-533-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-05) 55111-533-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-30) 55111-533-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-60) 55111-533-78 10 BLISTER PACK in 1 CARTON (55111-533-78) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-533-79)

Ingredients (1)

divalproex sodium (250 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": "bbff7587-1b4e-6616-e6f5-689bc89e1aea", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099563"], "spl_set_id": ["2e35f833-1cf7-12eb-9567-7a191e32e138"], "manufacturer_name": ["Dr. Reddy's Laboratories Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-01)", "package_ndc": "55111-533-01", "marketing_start_date": "20130811"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-05)", "package_ndc": "55111-533-05", "marketing_start_date": "20130811"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-30)", "package_ndc": "55111-533-30", "marketing_start_date": "20130811"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-60)", "package_ndc": "55111-533-60", "marketing_start_date": "20130811"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-533-78)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-533-79)", "package_ndc": "55111-533-78", "marketing_start_date": "20130811"}], "brand_name": "Divalproex Sodium", "product_id": "55111-533_bbff7587-1b4e-6616-e6f5-689bc89e1aea", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "55111-533", "generic_name": "Divalproex Sodium", "labeler_name": "Dr. Reddy's Laboratories Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex Sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "250 mg/1"}], "application_number": "ANDA090161", "marketing_category": "ANDA", "marketing_start_date": "20130811", "listing_expiration_date": "20261231"}