Divalproex Sodium
- Product NDC
- 65841-638
- 11-digit product format
- 658410638
- Labeler code
- 65841
- Product ID
- 65841-638_d0431c44-92e9-4479-b41f-809ec0b171bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex Sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA078239
- Marketing category
- ANDA
- Marketing start
- 2013-01-07
- Marketing end
- 0000-00-00
- Substance
- DIVALPROEX SODIUM
- Active strength
- 500 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIVALPROEX SODIUM | ACTIVE INGREDIENT | 644VL95AO6 | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-638 | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 8 | Legacy NDC | 20250409_4f40e035-fdad-42c9-bd31-c1582215f83e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65841-638-01 | 65841063801 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-638-01) | 2013-01-07 | 0000-00-00 | No | No | Current |
| 65841-638-05 | 65841063805 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-638-05) | 2013-01-07 | 0000-00-00 | No | No | Current |
| 65841-638-16 | 65841063816 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-638-16) | 2013-01-07 | 0000-00-00 | No | No | Current |