divalproex sodium (68180-266)

Drug Facts

Product Profile

Brand Name divalproex sodium

Generic Name divalproex sodium

Labeler lupin pharmaceuticals, inc.

Dosage Form TABLET, DELAYED RELEASE

Routes

ORAL

Active Ingredients

divalproex sodium 250 mg/1

Manufacturer

Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-266

Product ID 68180-266_22a92d77-5a45-42bf-9369-6bde7061495d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078790

Listing Expiration 2026-12-31

Marketing Start 2008-07-29

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 68180266

Hyphenated Format 68180-266

Supplemental Identifiers

RxCUI

1099625 1099678 1099870

UPC

0368180267010

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 ANDA078790 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

250 mg/1

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING Divalproex sodium delayed-release tablets USP are supplied as: 125 mg (as valproic acid) pink colored, oval shaped, biconvex, enteric coated tablets, imprinted with "L005" (in black ink) on one side and plain on the other side. Bottles of 100 NDC 68180-265-01 Bottles of 500 NDC 68180-265-02 Box containing 10 x 10's unit dose tablets NDC 68180-265-13 250 mg (as valproic acid) pink colored, oval shaped, biconvex, enteric coated tablets, imprinted with "L006" (in black ink) on one side and plain on the other side. Bottles of 100 NDC 68180-266-01 Bottles of 500 NDC 68180-266-02 Bottles of 1000 NDC 68180-266-03 Box containing 10 x 10's unit dose tablets NDC 68180-266-13 500 mg (as valproic acid) pink colored, oval shaped, biconvex, enteric coated tablets, imprinted with "L007" (in black ink) on one side and plain on the other side. Bottles of 100 NDC 68180-267-01 Bottles of 500 NDC 68180-267-02 Bottles of 1000 NDC 68180-267-03 Box containing 10 x 10's unit dose tablets NDC 68180-267-13 Recommended storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Divalproex Sodium Delayed-release Tablets USP, 125 mg Rx Only NDC 68180-265-01 100 Tablets Divalproex Sodium Delayed-release Tablets USP, 250 mg Rx Only NDC 68180-266-01 100 Tablets Divalproex Sodium Delayed-release Tablets USP, 500 mg Rx Only NDC 68180-267-01 100 Tablets Fig 6 Fig 7 Figure 8

source: label

Packages (0)

No package records.

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": "22a92d77-5a45-42bf-9369-6bde7061495d", "openfda": {"upc": ["0368180267010"], "unii": ["644VL95AO6"], "rxcui": ["1099625", "1099678", "1099870"], "spl_set_id": ["33798a7c-c5a9-49a5-be5d-1312910ef468"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Divalproex Sodium", "product_id": "68180-266_22a92d77-5a45-42bf-9369-6bde7061495d", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "68180-266", "generic_name": "Divalproex Sodium", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex Sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "250 mg/1"}], "application_number": "ANDA078790", "marketing_category": "ANDA", "marketing_start_date": "20080729", "listing_expiration_date": "20261231"}