Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Product NDC
- 68382-953
- 11-digit product format
- 683820953
- Labeler code
- 68382
- Product ID
- 68382-953_e599ddbf-b40d-4f8d-82dd-528dd90f5472
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA207340
- Marketing category
- ANDA
- Marketing start
- 2017-10-31
- Marketing end
- 0000-00-00
- Substance
- AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE
- Active strength
- 3 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68382-953-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a023-a426-e053-dadaa90af4c2 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68382-953-01 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | 100 in 1 BOTTLE | TABLET | 100 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68382-953-01 | EA - Each | 68382-953 | 2a198ccb-0e3b-4abc-8bb3-ae609d88a4ad | 1 | 2019-01-24 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68382-953 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC. ] | 5 | Legacy NDC, 1 package rows | 20200103_6bf5bcd5-bed6-4405-a61d-af593b4a3a43.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 | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 1009145 | dextroamphetamine saccharate 1.875 MG / amphetamine aspartate 1.875 MG / dextroamphetamine sulfate 1.875 MG / amphetamine sulfate 1.875 MG Oral Tablet | PSN | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 541892 | dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG Oral Tablet | PSN | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 687043 | dextroamphetamine saccharate 3.125 MG / amphetamine aspartate 3.125 MG / dextroamphetamine sulfate 3.125 MG / amphetamine sulfate 3.125 MG Oral Tablet | PSN | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 577957 | dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG Oral Tablet | PSN | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 577961 | dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG Oral Tablet | PSN | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 541363 | dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG Oral Tablet | PSN | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 541878 | amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Oral Tablet | SCD | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 1009145 | amphetamine aspartate 1.875 MG / amphetamine sulfate 1.875 MG / dextroamphetamine saccharate 1.875 MG / dextroamphetamine sulfate 1.875 MG Oral Tablet | SCD | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 541892 | amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Oral Tablet | SCD | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 687043 | amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Oral Tablet | SCD | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 577957 | amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Oral Tablet | SCD | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 577961 | amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Oral Tablet | SCD | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 541363 | amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral Tablet | SCD | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 541892 | mixed amphetamine salts 10 MG Oral Tablet | SY | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 687043 | mixed amphetamine salts 12.5 MG Oral Tablet | SY | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 577957 | mixed amphetamine salts 15 MG Oral Tablet | SY | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 577961 | mixed amphetamine salts 20 MG Oral Tablet | SY | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 541363 | mixed amphetamine salts 30 MG Oral Tablet | SY | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 541878 | mixed amphetamine salts 5 MG Oral Tablet | SY | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
| 1009145 | mixed amphetamine salts 7.5 MG Oral Tablet | SY | 6bf5bcd5-bed6-4405-a61d-af593b4a3a43 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68382-953-01 | 68382095301 | 100 TABLET in 1 BOTTLE (68382-953-01) | 100 tablet | 2017-10-31 | 0000-00-00 | No | No | Current |