Prescription drug · ANDA
Amphetamine Sulfate NDC 63629-2078
Amphetamine sulfate 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2078-1 | 63629207801 | 100 TABLET in 1 BOTTLE (63629-2078-1)Marketed from Dec 21, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Sulfate
- Generic name (nonproprietary)
- amphetamine sulfate
- Active ingredients
- Amphetamine sulfate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212901
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 63629-2078_50035f9b-feee-47ca-8786-af69aebc0cfbSPL ID 50035f9b-feee-47ca-8786-af69aebc0cfbSPL set ID 9eb84b3c-2147-42dd-8053-6afd1a88b0c1RxCUI 1600695UNII 6DPV8NK46S
- 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
N463629207801followed by a unit qualifier and the quantityPackage 63629-2078-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 212901
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 Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2524 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1088 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1087 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2525 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2990 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-106 |
| Amphetamine Sulfateamphetamine sulfate tablets | Amphetamine sulfate 10 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-107 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2079 |