DEXEDRINE
- Product NDC
- 64896-674
- 11-digit product format
- 648960674
- Labeler code
- 64896
- Product ID
- 64896-674_d5d5a976-872f-4849-b222-1fb433511511
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dextroamphetamine sulfate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- NDA017078
- Marketing category
- NDA
- Marketing start
- 1976-08-02
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DEXEDRINE
- Brand name suffix
- SPANSULE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROAMPHETAMINE SULFATE | 10 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | JJ768O327N |
| Rxcui | 884520, 884528, 884532, 884534, 884535, 884537 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0f66b30d-6b15-4b2d-91a5-1531b9bb6d21 | Product name | 7 | 20250625 |
| 917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2b | Product name | 2 | 20250616 |
| b4c312b9-fad5-247e-cef9-87a74220463d | Product name | 5 | 20230426 |
| 8170729e-5ba4-46f9-830f-5f0fae5942ce | Product name | 1 | 20230103 |
| 2a7aa275-a4ca-44eb-971f-47427a374085 | Product name | 9 | 20220615 |
| aa1b3c66-c4f6-78f2-abd3-31cc9d555e27 | Product name | 5 | 20190913 |
| b4c312b9-fad5-247e-cef9-87a74220463d | Product name | 4 | 20171211 |
| ffdf7f68-0f44-4dd6-a026-336dcb345fc4 | Product name | 1 | 20151109 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64896-674-10 | DEXEDRINESPANSULE | 1 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 1 | 15 | |
| 64896-674-10 | DEXEDRINESPANSULE | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64896-674-10 | EA - Each | 64896-674 | a92a247f-93a7-4899-80c1-c4361f645550 | 1 | 2019-03-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 884534 | Dexedrine 15 MG Extended Release Oral Capsule | PSN | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884528 | Dexedrine Spansule 10 MG Extended Release Oral Capsule | PSN | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884537 | Dexedrine Spansule 5 MG Extended Release Oral Capsule | PSN | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884520 | dextroamphetamine sulfate 10 MG Extended Release Oral Capsule | PSN | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884532 | dextroamphetamine sulfate 15 MG Extended Release Oral Capsule | PSN | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884535 | dextroamphetamine sulfate 5 MG Extended Release Oral Capsule | PSN | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884528 | dextroamphetamine sulfate 10 MG Extended Release Oral Capsule [Dexedrine] | SBD | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884534 | dextroamphetamine sulfate 15 MG Extended Release Oral Capsule [Dexedrine] | SBD | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884537 | dextroamphetamine sulfate 5 MG Extended Release Oral Capsule [Dexedrine] | SBD | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884520 | dextroamphetamine sulfate 10 MG Extended Release Oral Capsule | SCD | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884532 | dextroamphetamine sulfate 15 MG Extended Release Oral Capsule | SCD | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884535 | dextroamphetamine sulfate 5 MG Extended Release Oral Capsule | SCD | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884528 | Dexedrine 10 MG Extended Release Oral Capsule | SY | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884534 | Dexedrine 15 MG Extended Release Oral Capsule | SY | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
| 884537 | Dexedrine 5 MG Extended Release Oral Capsule | SY | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64896-674-10 | 64896067410 | 1 BOTTLE in 1 CARTON (64896-674-10) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 1976-08-02 | 0000-00-00 | No | No | Current |