Divalproex Sodium
- Product NDC
- 53808-1065
- 11-digit product format
- 538081065
- Labeler code
- 53808
- Product ID
- 53808-1065_9a4fc6df-9de5-42e6-9c30-57be15f3c153
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA090554
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- Marketing end
- 0000-00-00
- Substance
- DIVALPROEX SODIUM
- Active strength
- 250 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
- 2019-12-31
- 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 |
|---|
| 53808-1065-1 | Divalproex Sodium | 30 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIVALPROEX SODIUM | ACTIVE INGREDIENT | 644VL95AO6 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| METHYLENE CHLORIDE | INACTIVE INGREDIENT | 588X2YUY0A | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| VANILLIN | INACTIVE INGREDIENT | CHI530446X | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-1065 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20150107_c0469f5a-68ab-4dbc-a9c7-9a1043e350a5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-1065-1 | 53808106501 | 30 in 1 BLISTER PACK | Historical |