divalproex sodium
- Product NDC
- 65841-639
- 11-digit product format
- 658410639
- Labeler code
- 65841
- Product ID
- 65841-639_9b43fd1a-165d-420e-ba4f-f7bfaea4c283
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- divalproex sodium
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA078919
- Marketing category
- ANDA
- Marketing start
- 2009-01-27
- Substance
- DIVALPROEX SODIUM
- Active strength
- 125 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- divalproex sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIVALPROEX SODIUM | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 644VL95AO6 |
| Rxcui | 1099596 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65841-639-01 | divalproex sodium | 100 in 1 BOTTLE | CAPSULE, COATED PELLETS | 100 | | 9 |
| 65841-639-10 | divalproex sodium | 1000 in 1 BOTTLE | CAPSULE, COATED PELLETS | 1000 | | 9 |
| 65841-639-30 | divalproex sodium | 10 in 1 BLISTER PACK | CAPSULE, COATED PELLETS | 10 | | 9 |
| 65841-639-30 | divalproex sodium | 10 in 1 CARTON | CAPSULE, COATED PELLETS | 10 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIVALPROEX SODIUM | ACTIVE INGREDIENT | 644VL95AO6 | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-639 | DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS LIFESCIENCES LIMITED] | 9 | Current NDC, Legacy NDC, 4 package rows | 20241130_b0f33792-dd96-40cc-a28e-acdcdca2f4b8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65841-639-01 | 65841063901 | 100 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-01) | | 2009-01-27 | 0000-00-00 | No | No | Current |
| 65841-639-10 | 65841063910 | 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-10) | | 2009-01-27 | 0000-00-00 | No | No | Current |
| 65841-639-30 | 65841063930 | 10 BLISTER PACK in 1 CARTON (65841-639-30) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK | 10 blister pack | 2009-01-27 | 0000-00-00 | No | No | Current |