dextroamphetamine sulfate
- Product NDC
- 45963-304
- 11-digit product format
- 459630304
- Labeler code
- 45963
- Product ID
- 45963-304_efcdbc4d-7174-4356-9aa2-d557735e2048
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dextroamphetamine sulfate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA203901
- Marketing category
- ANDA
- Marketing start
- 2014-06-19
- Substance
- DEXTROAMPHETAMINE SULFATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- dextroamphetamine sulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROAMPHETAMINE SULFATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JJ768O327N |
| Rxcui | 884520, 884532, 884535 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45963-304-09 | dextroamphetamine sulfate | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXTROAMPHETAMINE SULFATE | ACTIVE INGREDIENT | JJ768O327N | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| DEXTROAMPHETAMINE | ACTIVE MOIETY | TZ47U051FI | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| OLEIC ACID | INACTIVE INGREDIENT | 2UMI9U37CP | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45963-304 | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 18 | Current NDC, Legacy NDC, 1 package rows | 20241025_9e92ccc3-d81c-461d-a19f-7e9b582be357.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45963-304-09 | 45963030409 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-304-09) | 2014-06-19 | 0000-00-00 | No | No | Current |