Prescription drug · ANDA
Amphetamine Sulfate NDC 0527-2525
Amphetamine sulfate 10 mg/1 · Tablet · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-2525-37 | 00527252537 | 100 TABLET in 1 BOTTLE (0527-2525-37)Marketed from Jun 1, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Amphetamine Sulfate
- Generic name (nonproprietary)
- amphetamine sulfate
- Active ingredients
- Amphetamine sulfate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212901
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0527-2525_23880d0f-9eea-4ef3-95aa-10fc11fcfa6cSPL ID 23880d0f-9eea-4ef3-95aa-10fc11fcfa6cSPL set ID 85a015a7-a1a0-4b04-8bc4-7aacd0c84742RxCUI 884655, 1600695UNII 6DPV8NK46SUPC 0305272524378, 0305272525375
- 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
N400527252537followed by a unit qualifier and the quantityPackage 00527-2525-37. 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: 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, le…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212901
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 Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2524 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1088 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1087 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2990 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-106 |
| Amphetamine Sulfateamphetamine sulfate tablets | Amphetamine sulfate 10 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-107 |
| Amphetamine Sulfate | Amphetamine sulfate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2079 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2078 |