Prescription drug · ANDA
Dextroamphetamine Sulfate NDC 13107-036
Dextroamphetamine sulfate 10 mg/1 · Tablet · Oral · Aurolife Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-036-01 | 13107003601 | 100 TABLET in 1 BOTTLE (13107-036-01)Marketed from Jul 31, 2013 | |
| 13107-036-50 | 13107003650 | 50 TABLET in 1 BOTTLE (13107-036-50)Marketed from Jul 31, 2013 | |
| 13107-036-99 | 13107003699 | 1000 TABLET in 1 BOTTLE (13107-036-99)Marketed from Jul 31, 2013 |
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)
- Dextroamphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine sulfate
- Active ingredients
- Dextroamphetamine sulfate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurolife Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202893
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 13107-036_9f989dfd-e290-448a-a66f-b22eaf61c9fdSPL ID 9f989dfd-e290-448a-a66f-b22eaf61c9fdSPL set ID 24163442-dd03-4066-a6ed-eb7e292b700bRxCUI 884385, 884386UNII 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
N413107003601followed by a unit qualifier and the quantityPackage 13107-0036-01. 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.
Other NDCs under ANDA 202893
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 |
|---|---|---|---|---|
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 5 mg/1 | TabletOral | Aurolife Pharma, LLC | 13107-035 |