Prescription drug · NDA AUTHORIZED GENERIC
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate NDC 66993-594
Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · Prasco Laboratories
NDC codes
FDA NDC DirectoryProduct NDC (as listed)66993-594Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66993-0594Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-594-02 | 6699305940266993059402 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-594-02)Marketed from Apr 2, 2009 |
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 monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
- Active ingredients
- Dextroamphetamine saccharate — 1.25 mg/1Amphetamine aspartate monohydrate — 1.25 mg/1Dextroamphetamine sulfate — 1.25 mg/1Amphetamine sulfate — 1.25 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Prasco LaboratoriesNDC labeler code 66993
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021303
- Marketing start
- Marketing end
- 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 66993-594_88228827-17de-42dd-a08c-aacf516e0156SPL ID 88228827-17de-42dd-a08c-aacf516e0156SPL set ID f85af6ee-9029-42de-adea-6dbb8642952cRxCUI 861221, 861223, 861225, 861227, 861232, 861237UNII G83415V073, JJ768O327N, 6DPV8NK46S, O1ZPV620O4UPC 0366993598024
- 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
N466993059402followed by a unit qualifier and the quantityPackage 66993-0594-02. 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)
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE extended-release capsules (MAS-ER Capsules), a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. ( 1 ) 1.1 Attention Deficit Hyperactivity Disorder MAS-ER Capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older.
Excerpt only. Read the full label for complete information.
About NDC 66993-594
- What is NDC 66993-594?
- 66993-594 is the product NDC for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients capsule, extended release, listed with the FDA by Prasco Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE).
- What is the active ingredient?
- Dextroamphetamine saccharate, Amphetamine aspartate monohydrate, Dextroamphetamine sulfate, Amphetamine sulfate.
- Who is the labeler?
- Prasco Laboratories, NDC labeler code 66993. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate?
- 105 other product NDCs are listed under this name. See all Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under NDA 021303
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 Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2368 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2371 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-385 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-381 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-383 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 7.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-391 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-387 |
| Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate | Dextroamphetamine sulfate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-389 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2329 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2335 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2343 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-596 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2352 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-595 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-599 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-597 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | Dextroamphetamine saccharate 6.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-598 |