Prescription drug · ANDA
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate NDC 57664-646
Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57664-646-08 | 5766406460857664064608 | 100 TABLET in 1 BOTTLE, PLASTIC (57664-646-08)Marketed from Sep 9, 2003 |
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 — 5 mg/1Amphetamine aspartate — 5 mg/1Dextroamphetamine sulfate — 5 mg/1Amphetamine sulfate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 57664
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040480
- 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 57664-646_177c0583-addd-49cc-e063-6394a90aa6ccSPL ID 177c0583-addd-49cc-e063-6394a90aa6ccSPL set ID 9af67219-9b37-45d0-ac52-647cbfacd296RxCUI 541363, 541878, 541892, 577957, 577961, 687043, 1009145UNII G83415V073, H527KAP6L5, JJ768O327N, 6DPV8NK46SUPC 0357664647080, 0357664642085, 0357664645086, 0357664644089, 0357664643082
- 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
N457664064608followed by a unit qualifier and the quantityPackage 57664-0646-08. 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 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be be…
Excerpt only. Read the full label for complete information.
About NDC 57664-646
- What is NDC 57664-646?
- 57664-646 is the product NDC for Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate, Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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.
- What is the active ingredient?
- Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, Amphetamine sulfate.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. 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 ANDA 040480
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.