Prescription drug · NDA
Adzenys XR-ODT (Amphetamine) NDC 70165-005
Amphetamine 3.1 mg/1 · Tablet, Orally disintegrating · Oral · Neos Therapeutics Brands, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70165-005-30 | 70165000530 | 30 BLISTER PACK in 1 CARTON (70165-005-30) / 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 — 3.1 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 70165-005_51b6449e-77c9-3dac-e063-6294a90aaeb6SPL ID 51b6449e-77c9-3dac-e063-6294a90aaeb6
- 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
N470165000530followed by a unit qualifier and the quantityPackage 70165-0005-30. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70165-005
- What is NDC 70165-005?
- 70165-005 is the product NDC for Adzenys XR-ODT (amphetamine), Amphetamine 3.1 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 6.3 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-010 | 70165-0010-30 |
| 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 |
| Adzenys XR-ODTamphetamine | Amphetamine 12.5 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-020 | 70165-0020-30 |
| Adzenys XR-ODTamphetamine | Amphetamine 9.4 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-015 | 70165-0015-30 |
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 |
|---|---|---|---|---|
| Adzenys XR-ODTamphetamine | Amphetamine 6.3 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-010 |
| 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 |
| Adzenys XR-ODTamphetamine | Amphetamine 12.5 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-020 |
| Adzenys XR-ODTamphetamine | Amphetamine 9.4 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-015 |
| 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 9.4 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-015 |
| 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 |