Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII
- Product NDC
- 47781-176
- 11-digit product format
- 477810176
- Labeler code
- 47781
- Product ID
- 47781-176_0374f0f7-9297-810c-38b3-623a72709a7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 10 mg,Cll
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alvogen Inc.
- Application
- ANDA207388
- Marketing category
- ANDA
- Marketing start
- 2017-07-28
- Substance
- AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
- Active strength
- 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], 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
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMPHETAMINE ASPARTATE MONOHYDRATE | 2.5 mg/1 |
| AMPHETAMINE SULFATE | 2.5 mg/1 |
| DEXTROAMPHETAMINE SACCHARATE | 2.5 mg/1 |
| DEXTROAMPHETAMINE SULFATE | 2.5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6DPV8NK46S, JJ768O327N, O1ZPV620O4, G83415V073 |
| Rxcui | 541363, 541878, 541892, 577957, 577961, 687043, 1009145 |
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 |
| 8b92ab59-8b26-4c89-a2d6-8d5140526ec6 | Product name | 3 | 20231213 |
| b4c312b9-fad5-247e-cef9-87a74220463d | Product name | 5 | 20230426 |
| 8170729e-5ba4-46f9-830f-5f0fae5942ce | Product name | 1 | 20230103 |
| 4496d022-9224-4ee0-943a-50fbe6cd7123 | Product name | 2 | 20220901 |
| 2a7aa275-a4ca-44eb-971f-47427a374085 | Product name | 9 | 20220615 |
| 93730fbf-8b45-4623-b27d-cf03825d04b3 | Product name | 5 | 20220314 |
| aa1b3c66-c4f6-78f2-abd3-31cc9d555e27 | Product name | 5 | 20190913 |
| b4c312b9-fad5-247e-cef9-87a74220463d | Product name | 4 | 20171211 |
| 57953747-955c-4dd8-9164-49d8ea877eae | Product name | 1 | 20171113 |
| fcc7ea58-a369-4e91-b092-5cde9ac2669f | Product name | 1 | 20160224 |
| ffdf7f68-0f44-4dd6-a026-336dcb345fc4 | Product name | 1 | 20151109 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47781-176-01 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII | 100 in 1 BOTTLE | TABLET | 100 | 15 | |
| 47781-176-05 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII | 500 in 1 BOTTLE | TABLET | 500 | 15 | |
| 47781-176-30 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII | 30 in 1 BOTTLE | TABLET | 30 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 47781-176-01 | EA - Each | 47781-176 | 11be5fa2-ed42-4d60-870e-32aa9d91a692 | 1 | 2019-08-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 47781-176 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS, 5 MG,CLL) TABLET DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS, 7.5 MG,CLL) TABLET DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS, 10 MG,CLL) TABLET DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS, 12.5 MG,CLL) TABLET DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMP | 15 | Current NDC, Legacy NDC, 3 package rows | 20250507_c907301d-e24d-9609-5529-fed14f94549f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 541878 | dextroamphetamine saccharate 1.25 MG / amphetamine aspartate 1.25 MG / dextroamphetamine sulfate 1.25 MG / amphetamine sulfate 1.25 MG Oral Tablet | PSN | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 1009145 | dextroamphetamine saccharate 1.875 MG / amphetamine aspartate 1.875 MG / dextroamphetamine sulfate 1.875 MG / amphetamine sulfate 1.875 MG Oral Tablet | PSN | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 541892 | dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG Oral Tablet | PSN | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 687043 | dextroamphetamine saccharate 3.125 MG / amphetamine aspartate 3.125 MG / dextroamphetamine sulfate 3.125 MG / amphetamine sulfate 3.125 MG Oral Tablet | PSN | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 577957 | dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG Oral Tablet | PSN | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 577961 | dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG Oral Tablet | PSN | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 541363 | dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG Oral Tablet | PSN | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 541878 | amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Oral Tablet | SCD | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 1009145 | amphetamine aspartate 1.875 MG / amphetamine sulfate 1.875 MG / dextroamphetamine saccharate 1.875 MG / dextroamphetamine sulfate 1.875 MG Oral Tablet | SCD | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 541892 | amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Oral Tablet | SCD | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 687043 | amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Oral Tablet | SCD | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 577957 | amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Oral Tablet | SCD | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 577961 | amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Oral Tablet | SCD | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 541363 | amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral Tablet | SCD | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 541892 | mixed amphetamine salts 10 MG Oral Tablet | SY | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 687043 | mixed amphetamine salts 12.5 MG Oral Tablet | SY | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 577957 | mixed amphetamine salts 15 MG Oral Tablet | SY | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 577961 | mixed amphetamine salts 20 MG Oral Tablet | SY | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 541363 | mixed amphetamine salts 30 MG Oral Tablet | SY | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 541878 | mixed amphetamine salts 5 MG Oral Tablet | SY | c907301d-e24d-9609-5529-fed14f94549f | 15 |
| 1009145 | mixed amphetamine salts 7.5 MG Oral Tablet | SY | c907301d-e24d-9609-5529-fed14f94549f | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 47781-176-01 | 47781017601 | 100 TABLET in 1 BOTTLE (47781-176-01) | 100 tablet | 2017-07-28 | 0000-00-00 | No | No | Current |
| 47781-176-05 | 47781017605 | 500 in 1 BOTTLE | Historical | |||||
| 47781-176-30 | 47781017630 | 30 in 1 BOTTLE | Historical |