Prescription drug · ANDA
Dextroamphetamine Sulfate NDC 63629-2375
Dextroamphetamine sulfate 5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2375-1 | 63629237501 | 100 TABLET in 1 BOTTLE (63629-2375-1)Marketed from Jul 4, 2018 |
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)
- Dextroamphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine sulfate
- Active ingredients
- Dextroamphetamine sulfate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210059
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 63629-2375_935d7a76-736a-44f2-a94f-fdcc72afe034SPL ID 935d7a76-736a-44f2-a94f-fdcc72afe034
- 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
N463629237501followed by a unit qualifier and the quantityPackage 63629-2375-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 63629-2375
- What is NDC 63629-2375?
- 63629-2375 is the product NDC for Dextroamphetamine Sulfate, Dextroamphetamine sulfate 5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dextroamphetamine Sulfate.
- What is the active ingredient?
- Dextroamphetamine sulfate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dextroamphetamine Sulfate?
- 38 other product NDCs are listed under this name. See all Dextroamphetamine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dextroamphetamine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 5 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-089 | 27808-0089-01 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 10 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-090 | 27808-0090-01 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 15 mg/1 | TabletOral | Winder Laboratories LLC | 75826-124 | 75826-0124-1075826-0124-30 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 20 mg/1 | TabletOral | Winder Laboratories LLC | 75826-125 | 75826-0125-1075826-0125-30 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 30 mg/1 | TabletOral | Winder Laboratories LLC | 75826-126 | 75826-0126-1075826-0126-30 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 2.5 mg/1 | TabletOral | Winder Laboratories LLC | 75826-120 | 75826-0120-1075826-0120-30 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 5 mg/1 | TabletOral | Winder Laboratories LLC | 75826-121 | 75826-0121-1075826-0121-30 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 7.5 mg/1 | TabletOral | Winder Laboratories LLC | 75826-122 | 75826-0122-1075826-0122-30 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 10 mg/1 | TabletOral | Winder Laboratories LLC | 75826-123 | 75826-0123-1075826-0123-30 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 15 mg/1 | TabletOral | Wilshire Pharmaceuticals, Inc. | 52536-515 | 52536-0515-03 |
Other NDCs under ANDA 210059
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 | Bryant Ranch Prepack | 72162-1233 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1234 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 5 mg/1 | TabletOral | SUNRISE PHARMACEUTICAL, INC. | 11534-188 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 10 mg/1 | TabletOral | SUNRISE PHARMACEUTICAL, INC. | 11534-189 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2374 |