Prescription drug · ANDA
Amphetamine sulfate (Amphetamine sulfate tablets) NDC 43598-898
Amphetamine sulfate 10 mg/1 · Tablet · Oral · DR. REDDY'S LABORATORIES INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-898-01 | 4359808980143598089801 | 100 TABLET in 1 BOTTLE (43598-898-01)Marketed from Mar 1, 2020 |
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)
- Amphetamine sulfate
- Generic name (nonproprietary)
- amphetamine sulfate tablets
- Active ingredients
- Amphetamine sulfate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- DR. REDDY'S LABORATORIES INCNDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212582
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 43598-898_6804c1a2-f648-b841-1d39-74d8624881e0SPL ID 6804c1a2-f648-b841-1d39-74d8624881e0SPL set ID 79b9db39-7cdc-5607-f0ce-ac2a2cfd59d5RxCUI 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
N443598089801followed by a unit qualifier and the quantityPackage 43598-0898-01. 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 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, learning disability, …
Excerpt only. Read the full label for complete information.
About NDC 43598-898
- What is NDC 43598-898?
- 43598-898 is the product NDC for Amphetamine sulfate (amphetamine sulfate tablets), Amphetamine sulfate 10 mg/1 tablet, listed with the FDA by DR. REDDY'S LABORATORIES INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amphetamine sulfate (Amphetamine Sulfate Tablets).
- What is the active ingredient?
- Amphetamine sulfate.
- Who is the labeler?
- DR. REDDY'S LABORATORIES INC, NDC labeler code 43598. 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 5 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2524 | 00527-2524-37 |
| Amphetamine Sulfate | Amphetamine sulfate 10 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2525 | 00527-2525-37 |
Other NDCs under ANDA 212582
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 sulfate tablets | Amphetamine sulfate 5 mg/1 | TabletOral | DR. REDDY'S LABORATORIES INC | 43598-897 |