divalproex sodium

Generic: divalproex sodium

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

divalproex sodium 125 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-115
Product ID 27241-115_d905fd66-055a-4130-8e67-20c0645362f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213181
Listing Expiration 2027-12-31
Marketing Start 2020-05-15

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 27241115
Hyphenated Format 27241-115

Supplemental Identifiers

RxCUI
1099596
UPC
0327241115011
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 ANDA213181 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 100 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-01)
  • 500 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-05)
  • 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-10)
source: ndc

Packages (3)

27241-115-01 100 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-01) 27241-115-05 500 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-05) 27241-115-10 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-10)

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": "d905fd66-055a-4130-8e67-20c0645362f0", "openfda": {"upc": ["0327241115011"], "unii": ["644VL95AO6"], "rxcui": ["1099596"], "spl_set_id": ["773a289b-65ed-4045-80c5-f00e28c1c079"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-01)", "package_ndc": "27241-115-01", "marketing_start_date": "20200515"}, {"sample": false, "description": "500 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-05)", "package_ndc": "27241-115-05", "marketing_start_date": "20200515"}, {"sample": false, "description": "1000 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-10)", "package_ndc": "27241-115-10", "marketing_start_date": "20200515"}], "brand_name": "Divalproex sodium", "product_id": "27241-115_d905fd66-055a-4130-8e67-20c0645362f0", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "27241-115", "generic_name": "Divalproex sodium", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "125 mg/1"}], "application_number": "ANDA213181", "marketing_category": "ANDA", "marketing_start_date": "20200515", "listing_expiration_date": "20271231"}