Prescription drug · ANDA
Amphetamine Sulfate (Amphetamine) NDC 69238-1564
Amphetamine sulfate 10 mg/1 · Tablet · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1564-1 | 69238156401 | 100 TABLET in 1 BOTTLE (69238-1564-1)Marketed from Sep 28, 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)
- Amphetamine Sulfate
- Generic name (nonproprietary)
- amphetamine
- Active ingredients
- Amphetamine sulfate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211139
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 69238-1564_940571ac-35e3-426e-8eb0-386a3987c3b9SPL ID 940571ac-35e3-426e-8eb0-386a3987c3b9SPL set ID 53d40847-e0d3-48ec-81a7-ec5478553565RxCUI 884655, 1600695UNII 6DPV8NK46S
- 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
N469238156401followed by a unit qualifier and the quantityPackage 69238-1564-01. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Amphetamine sulfate tablets, USP 5 mg and 10 mg are indicated for: 1. Narcolepsy 2. 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 sig…
Excerpt only. Read the full label for complete information.
About NDC 69238-1564
- What is NDC 69238-1564?
- 69238-1564 is the product NDC for Amphetamine Sulfate (amphetamine), Amphetamine sulfate 10 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amphetamine Sulfate (Amphetamine).
- What is the active ingredient?
- Amphetamine sulfate.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amphetamine Sulfate?
- 32 other product NDCs are listed under this name. See all Amphetamine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amphetamine 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) |
|---|---|---|---|---|---|
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-106 | 69292-0106-01 |
| Amphetamine Sulfateamphetamine sulfate tablets | Amphetamine sulfate 10 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-107 | 69292-0107-01 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | SpecGx LLC | 0406-1219 | 00406-1219-01 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | SpecGx LLC | 0406-1220 | 00406-1220-01 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Epic Pharma LLC | 42806-029 | 42806-0029-01 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Epic Pharma LLC | 42806-030 | 42806-0030-01 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1114 | 63629-1114-01 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1115 | 63629-1115-01 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2078 | 63629-2078-01 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2079 | 63629-2079-01 |
Other NDCs under ANDA 211139
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 |
|---|---|---|---|---|
| Amphetamine Sulfateamphetamine | Amphetamine sulfate 5 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1563 |