Divalproex Sodium
- Product NDC
- 21695-819
- 11-digit product format
- 216950819
- Labeler code
- 21695
- Product ID
- 21695-819_9b3db659-f64c-4c48-946a-6b4f1d800eba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA078790
- Marketing category
- ANDA
- Marketing start
- 2009-10-14
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-819-60 | Divalproex SodiumDR | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 1 |
| 21695-819-90 | Divalproex SodiumDR | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIVALPROEX SODIUM | ACTIVE INGREDIENT | 644VL95AO6 | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-819 | DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 2 package rows | 20110429_9b3db659-f64c-4c48-946a-6b4f1d800eba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-819-60 | 21695081960 | 60 in 1 BOTTLE | Historical |
| 21695-819-90 | 21695081990 | 90 in 1 BOTTLE | Historical |