MYDAYIS
- Product NDC
- 54092-477
- 11-digit product format
- 540920477
- Labeler code
- 54092
- Product ID
- 54092-477_13a2ab7d-af84-4e46-a58f-9e9c17b5c0e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- NDA022063
- Marketing category
- NDA
- Marketing start
- 2017-06-20
- Substance
- AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
- Active strength
- 12.5; 12.5; 12.5; 12.5 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MYDAYIS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMPHETAMINE ASPARTATE MONOHYDRATE | 12.5 mg/1 |
| AMPHETAMINE SULFATE | 12.5 mg/1 |
| DEXTROAMPHETAMINE SACCHARATE | 12.5 mg/1 |
| DEXTROAMPHETAMINE SULFATE | 12.5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6DPV8NK46S, G83415V073, O1ZPV620O4, JJ768O327N |
| Rxcui | 1927610, 1927616, 1927617, 1927619, 1927630, 1927632, 1927637, 1927639 |
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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|---|---|---|---|
| 54092-477-01 | MYDAYIS | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54092-477-01 | EA - Each | 54092-477 | 626aa89a-715c-4cf5-9bea-8a431cc01a47 | 1 | 2017-07-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54092-477 | MYDAYIS (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AND AMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20250321_141a7970-3f06-44ea-9ab7-aeece2c085fc.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1927610 | amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG 3-Bead 24HR Extended Release Oral Capsule | PSN | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927630 | amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG 3-Bead 24HR Extended Release Oral Capsule | PSN | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927617 | amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 3-Bead 24HR Extended Release Oral Capsule | PSN | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927637 | amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG 3-Bead 24HR Extended Release Oral Capsule | PSN | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927632 | Mydayis 12.5 MG 24HR Extended Release Oral Capsule | PSN | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927619 | Mydayis 25 MG 24HR Extended Release Oral Capsule | PSN | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927639 | Mydayis 37.5 MG 24HR Extended Release Oral Capsule | PSN | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927616 | Mydayis 50 MG 24HR Extended Release Oral Capsule | PSN | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927616 | 3-Bead 24 HR amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG Extended Release Oral Capsule [Mydayis] | SBD | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927632 | 3-Bead 24 HR amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Extended Release Oral Capsule [Mydayis] | SBD | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927619 | 3-Bead 24 HR amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG Extended Release Oral Capsule [Mydayis] | SBD | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927639 | 3-Bead 24 HR amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG Extended Release Oral Capsule [Mydayis] | SBD | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927610 | 3-Bead 24 HR amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG Extended Release Oral Capsule | SCD | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927630 | 3-Bead 24 HR amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Extended Release Oral Capsule | SCD | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927617 | 3-Bead 24 HR amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG Extended Release Oral Capsule | SCD | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927637 | 3-Bead 24 HR amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG Extended Release Oral Capsule | SCD | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927610 | amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG 3-Bead 24HR Extended Release Oral Capsule | SY | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927630 | amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG 3-Bead 24HR Extended Release Oral Capsule | SY | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927617 | amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 3-Bead 24HR Extended Release Oral Capsule | SY | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927637 | amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG 3-Bead 24HR Extended Release Oral Capsule | SY | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927632 | Mydayis 12.5 MG 24HR Extended Release Oral Capsule | SY | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927619 | Mydayis 25 MG 24HR Extended Release Oral Capsule | SY | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927639 | Mydayis 37.5 MG 24HR Extended Release Oral Capsule | SY | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
| 1927616 | Mydayis 50 MG 24HR Extended Release Oral Capsule | SY | 141a7970-3f06-44ea-9ab7-aeece2c085fc | 13 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 54092-477-01 | 54092047701 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-477-01) | 2017-06-20 | 0000-00-00 | No | No | Current |