Prescription drug · ANDA
Procentra (Dextroamphetamine sulfate) NDC 21724-701
Dextroamphetamine sulfate 5 mg/5mL · Solution · Oral · INDEPENDENCE PHARMACEUTICALS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21724-701-05 | 21724070105 | 473 mL in 1 BOTTLE, PLASTIC (21724-701-05)Marketed from May 15, 2014 |
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)
- Procentra
- Generic name (nonproprietary)
- dextroamphetamine sulfate
- Active ingredients
- Dextroamphetamine sulfate — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- INDEPENDENCE PHARMACEUTICALS, LLCNDC labeler code 21724
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040776
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 21724-701_06b4c32e-1880-40e9-9de2-0927cb8c1500SPL ID 06b4c32e-1880-40e9-9de2-0927cb8c1500SPL set ID 1548cce2-fb6b-4f17-8a3b-868933f6c9d6RxCUI 884522, 884526UNII 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
N421724070105followed by a unit qualifier and the quantityPackage 21724-0701-05. 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)
INDICATIONS AND USAGE Dextroamphetamine Sulfate Oral Solution is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotionally lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizi…
Excerpt only. Read the full label for complete information.
About NDC 21724-701
- What is NDC 21724-701?
- 21724-701 is the product NDC for Procentra (dextroamphetamine sulfate), Dextroamphetamine sulfate 5 mg/5mL solution, listed with the FDA by INDEPENDENCE PHARMACEUTICALS, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Procentra (Dextroamphetamine sulfate).
- What is the active ingredient?
- Dextroamphetamine sulfate.
- Who is the labeler?
- INDEPENDENCE PHARMACEUTICALS, LLC, NDC labeler code 21724. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Procentra?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 040776
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/5mL | SolutionOral | Prasco Laboratories | 66993-359 |