Prescription drug · NDA
Adzenys XR-ODT (Amphetamine) NDC 70165-010
Amphetamine 6.3 mg/1 · Tablet, Orally disintegrating · Oral · Neos Therapeutics Brands, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70165-010-30 | 70165001030 | 30 BLISTER PACK in 1 CARTON (70165-010-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Feb 16, 2016 |
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)
- Adzenys XR-ODT
- Generic name (nonproprietary)
- amphetamine
- Active ingredients
- Amphetamine — 6.3 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Neos Therapeutics Brands, LLCNDC labeler code 70165
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204326
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 70165-010_512c5af5-6bf8-ace1-e063-6394a90ad807SPL ID 512c5af5-6bf8-ace1-e063-6394a90ad807SPL set ID c1179269-00b5-48ea-972d-31e614e99b7eRxCUI 1739803, 1739809, 1739813, 1739815, 1739819, 1739821, 1739825, 1739827, 1739831, 1739833, 1739837, 1739839UNII CK833KGX7EUPC 0370165015301, 0370165010306, 0370165030304, 0370165005302, 0370165025300, 0370165020305
- 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
N470165001030followed by a unit qualifier and the quantityPackage 70165-0010-30. 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)
1. INDICATIONS AND USAGE ADZENYS XR-ODT 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 ADZENYS XR-ODT 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)] . ADZENYS XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADH…
Excerpt only. Read the full label for complete information.
About NDC 70165-010
- What is NDC 70165-010?
- 70165-010 is the product NDC for Adzenys XR-ODT (amphetamine), Amphetamine 6.3 mg/1 tablet, orally disintegrating, listed with the FDA by Neos Therapeutics Brands, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Adzenys XR-ODT (Amphetamine).
- What is the active ingredient?
- Amphetamine.
- Who is the labeler?
- Neos Therapeutics Brands, LLC, NDC labeler code 70165. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Adzenys XR-ODT?
- 5 other product NDCs are listed under this name. See all Adzenys XR-ODT NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Adzenys XR-ODT products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Adzenys XR-ODTamphetamine | Amphetamine 3.1 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-005 | 70165-0005-30 |
| Adzenys XR-ODTamphetamine | Amphetamine 9.4 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-015 | 70165-0015-30 |
| Adzenys XR-ODTamphetamine | Amphetamine 12.5 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-020 | 70165-0020-30 |
| Adzenys XR-ODTamphetamine | Amphetamine 15.7 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-025 | 70165-0025-30 |
| Adzenys XR-ODTamphetamine | Amphetamine 18.8 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-030 | 70165-0030-30 |
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 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 9.4 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-015 |
| Amphetamine Extended-Release | Amphetamine 12.5 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-020 |
| 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 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 |