Prescription drug · ANDA
Zenzedi (Dextroamphetamine sulfate) NDC 24338-855
Dextroamphetamine sulfate 20 mg/1 · Tablet · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24338-855-03 | 2433808550324338085503 | 30 TABLET in 1 BOTTLE (24338-855-03)Marketed from Mar 12, 2021 |
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)
- Zenzedi
- Generic name (nonproprietary)
- dextroamphetamine sulfate
- Active ingredients
- Dextroamphetamine sulfate — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Azurity Pharmaceuticals, Inc.NDC labeler code 24338
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090533
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 24338-855_67939d07-156a-4af8-9520-3c0b146aa681SPL ID 67939d07-156a-4af8-9520-3c0b146aa681SPL set ID d6394df5-f2c9-47eb-b57e-f3e9cfd94f84RxCUI 884385, 884386, 884684, 1425337, 1425339, 1425847, 1425854, 1426251, 1426253, 1535451, 1535454, 1535456, 1535470, 1535472UNII JJ768O327NUPC 0324338854037, 0324338855034, 0324338851036, 0324338850039, 0324338852033, 0324338853030, 0324338856031
- 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
N424338085503followed by a unit qualifier and the quantityPackage 24338-0855-03. 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 Zenzedi ® (Dextroamphetamine Sulfate Tablets, USP) is indicated for: Narcolepsy . Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonl…
Excerpt only. Read the full label for complete information.
About NDC 24338-855
- What is NDC 24338-855?
- 24338-855 is the product NDC for Zenzedi (dextroamphetamine sulfate), Dextroamphetamine sulfate 20 mg/1 tablet, listed with the FDA by Azurity Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zenzedi (Dextroamphetamine Sulfate).
- What is the active ingredient?
- Dextroamphetamine sulfate.
- Who is the labeler?
- Azurity Pharmaceuticals, Inc., NDC labeler code 24338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zenzedi?
- 6 other product NDCs are listed under this name. See all Zenzedi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zenzedi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 15 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-854 | 24338-0854-03 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 30 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-856 | 24338-0856-03 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 2.5 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-850 | 24338-0850-03 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 5 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-851 | 24338-0851-03 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 7.5 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-852 | 24338-0852-03 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 10 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-853 | 24338-0853-03 |
Other NDCs under ANDA 090533
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 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2350 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2349 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 15 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2351 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2352 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2353 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 15 mg/1 | TabletOral | Wilshire Pharmaceuticals, Inc. | 52536-515 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 5 mg/1 | TabletOral | Wilshire Pharmaceuticals, Inc. | 52536-500 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 10 mg/1 | TabletOral | Wilshire Pharmaceuticals, Inc. | 52536-510 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 20 mg/1 | TabletOral | Wilshire Pharmaceuticals, Inc. | 52536-520 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 30 mg/1 | TabletOral | Wilshire Pharmaceuticals, Inc. | 52536-530 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 10 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-853 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 2.5 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-850 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 5 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-851 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 7.5 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-852 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 15 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-854 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 30 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-856 |