Prescription drug · ANDA
Dextroamphetamine Sulfate NDC 52536-530
Dextroamphetamine sulfate 30 mg/1 · Tablet · Oral · Wilshire Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52536-530-03 | 52536053003 | 30 TABLET in 1 BOTTLE (52536-530-03)Marketed from Aug 6, 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)
- Dextroamphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine sulfate
- Active ingredients
- Dextroamphetamine sulfate — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- 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 52536-530_3777bded-3f46-0856-e063-6394a90a47b4SPL ID 3777bded-3f46-0856-e063-6394a90a47b4SPL set ID 6b8c97ac-c83c-4a1f-a33c-121239253abfRxCUI 884385, 884386, 884684, 1535454, 1535470UNII JJ768O327NUPC 0352536520034, 0352536510035, 0352536515030, 0352536530033, 0352536500036
- 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
N452536053003followed by a unit qualifier and the quantityPackage 52536-0530-03. 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 Dextroamphetamine sulfate tablets, USP are 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. Nonlocalizing (s…
Excerpt only. Read the full label for complete information.
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 15 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2351 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2349 |
| Dextroamphetamine Sulfate | Dextroamphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2350 |
| 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 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 2.5 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-850 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 10 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-853 |
| 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 20 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-855 |
| Zenzedidextroamphetamine sulfate | Dextroamphetamine sulfate 30 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-856 |
| 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 |