Prescription drug · ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate NDC 70010-114
Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients · Tablet · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-114-01 | 70010011401 | 100 TABLET in 1 BOTTLE (70010-114-01)Marketed from Mar 28, 2023 | |
| 70010-114-03 | 70010011403 | 30 TABLET in 1 BOTTLE (70010-114-03)Marketed from Apr 30, 2024 |
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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
- Active ingredients
- Dextroamphetamine saccharate — 3.125 mg/1Amphetamine aspartate monohydrate — 3.125 mg/1Dextroamphetamine sulfate — 3.125 mg/1Amphetamine sulfate — 3.125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215771
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 70010-114_56c7c921-e560-c5ad-e063-6294a90a4c81SPL ID 56c7c921-e560-c5ad-e063-6294a90a4c81SPL set ID b0b4eccc-34c7-483d-966f-82d588358e1bRxCUI 541363, 541878, 541892, 577957, 577961, 687043, 1009145UNII O1ZPV620O4, G83415V073, 6DPV8NK46S, JJ768O327NUPC 0370010117037, 0370010113039, 0370010111035, 0370010116030, 0370010115033
- 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
N470010011401followed by a unit qualifier and the quantityPackage 70010-0114-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 215771
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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients | TabletOral | Granules Pharmaceuticals Inc. | 70010-111 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients | TabletOral | Granules Pharmaceuticals Inc. | 70010-115 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine saccharate 1.875 mg/1 + 3 more ingredients | TabletOral | Granules Pharmaceuticals Inc. | 70010-112 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients | TabletOral | Granules Pharmaceuticals Inc. | 70010-113 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients | TabletOral | Granules Pharmaceuticals Inc. | 70010-116 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Amphetamine aspartate monohydrate 7.5 mg/1 + 3 more ingredients | TabletOral | Granules Pharmaceuticals Inc. | 70010-117 |