Prescription drug · ANDA
Evekeo (amphetamine sulfate) NDC 24338-022
Amphetamine sulfate 5 mg/1 · Tablet · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24338-022-03 | 24338002203 | 30 TABLET in 1 BOTTLE (24338-022-03)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)
- Evekeo
- Generic name (nonproprietary)
- amphetamine sulfate
- Active ingredients
- Amphetamine sulfate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200166
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 24338-022_d0fd9643-77a8-4810-94f5-f0ab06e4212fSPL ID d0fd9643-77a8-4810-94f5-f0ab06e4212fSPL set ID f469fb38-0380-4621-9db3-a4f429126156RxCUI 884655, 1600695, 1600698, 1600700UNII 6DPV8NK46SUPC 0324338022030, 0324338026038
- 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
N424338002203followed by a unit qualifier and the quantityPackage 24338-0022-03. 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 Evekeo ® (amphetamine 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 children with 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 the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learnin…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200166
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 |
|---|---|---|---|---|
| Evekeoamphetamine sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-026 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1612 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1613 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2498 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Wilshire Pharmaceuticals, Inc. | 52536-057 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2499 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Wilshire Pharmaceuticals, Inc. | 52536-059 |