Prescription drug · NDA AUTHORIZED GENERIC
Amphetamine Extended-Release NDC 62542-015
Amphetamine 9.4 mg/1 · Tablet, Orally disintegrating · Oral · Neos Therapeutics, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62542-015-30 | 62542001530 | 30 BLISTER PACK in 1 CARTON (62542-015-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Sep 1, 2025 |
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)
- Amphetamine Extended-Release
- Generic name (nonproprietary)
- amphetamine extended-release
- Active ingredients
- Amphetamine — 9.4 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Neos Therapeutics, LP
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 204326
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 62542-015_3f9283a3-e922-36ca-e063-6394a90a409dSPL ID 3f9283a3-e922-36ca-e063-6394a90a409dSPL set ID 48d0f55c-f847-4d26-b2ed-94b5a2770228RxCUI 1739803, 1739813, 1739819, 1739825, 1739831, 1739837UNII CK833KGX7EUPC 0362542030304, 0362542005302, 0362542010306, 0362542015301, 0362542025300, 0362542020305
- 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
N462542001530followed by a unit qualifier and the quantityPackage 62542-0015-30. 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)
Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies ( 14 )]. Limitations of Use The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4) ]. Amphetamine extended-release orally disintegrating tablets is a central…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 204326
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 |
|---|---|---|---|---|
| Amphetamine Extended-Release | Amphetamine 12.5 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-020 |
| Amphetamine Extended-Release | Amphetamine 3.1 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-005 |
| Amphetamine Extended-Release | Amphetamine 6.3 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-010 |
| Amphetamine Extended-Release | Amphetamine 15.7 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-025 |
| Amphetamine Extended-Release | Amphetamine 18.8 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-030 |
| Adzenys XR-ODTamphetamine | Amphetamine 3.1 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-005 |
| Adzenys XR-ODTamphetamine | Amphetamine 6.3 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-010 |
| Adzenys XR-ODTamphetamine | Amphetamine 9.4 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-015 |
| Adzenys XR-ODTamphetamine | Amphetamine 12.5 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-020 |
| Adzenys XR-ODTamphetamine | Amphetamine 15.7 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-025 |
| Adzenys XR-ODTamphetamine | Amphetamine 18.8 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-030 |