Prescription drug · NDA
Mydayis NDC 54092-477
Dextroamphetamine sulfate 12.5 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54092-477-01 | 54092047701 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-477-01)Marketed from Jun 20, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mydayis
- Generic name (nonproprietary)
- dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate
- Active ingredients
- Dextroamphetamine sulfate — 12.5 mg/1Dextroamphetamine saccharate — 12.5 mg/1Amphetamine aspartate monohydrate — 12.5 mg/1Amphetamine sulfate — 12.5 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022063
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 54092-477_13a2ab7d-af84-4e46-a58f-9e9c17b5c0e5SPL ID 13a2ab7d-af84-4e46-a58f-9e9c17b5c0e5SPL set ID 141a7970-3f06-44ea-9ab7-aeece2c085fcRxCUI 1927610, 1927616, 1927617, 1927619, 1927630, 1927632, 1927637, 1927639UNII O1ZPV620O4, G83415V073, 6DPV8NK46S, JJ768O327N
- Pharmacologic class
- Central Nervous System Stimulant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N454092047701followed by a unit qualifier and the quantityPackage 54092-0477-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
MYDAYIS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14) ] . MYDAYIS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. ( 1 ) Limitations of Use : Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite. ( 8.4 ) Limitations of Use : Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at th…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022063
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Mydayisdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate | Dextroamphetamine sulfate 9.375 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-474 |
| Mydayisdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate | Dextroamphetamine sulfate 3.125 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-468 |
| Mydayisdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate | Dextroamphetamine sulfate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-471 |