Prescription drug · ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate NDC 35573-464
Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · Burel Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35573-464-02 | 3557304640235573046402 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-464-02)Marketed from Dec 16, 2019 |
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 Monohydrate, 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/1Dextroamphetamine sulfate — 1.25 mg/1Amphetamine aspartate monohydrate — 1.25 mg/1Amphetamine sulfate — 1.25 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Burel Pharmaceuticals, LLCNDC labeler code 35573
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212037
- 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 35573-464_01fe666a-d04e-4dce-af71-8db45bbde653SPL ID 01fe666a-d04e-4dce-af71-8db45bbde653SPL set ID bcdd2fe2-d0de-4a28-aced-40ac9ce5122dRxCUI 861221, 861223, 861225, 861227, 861232, 861237UNII G83415V073, JJ768O327N, 6DPV8NK46S, O1ZPV620O4UPC 0335573466022, 0335573468026, 0335573467029
- 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
N435573046402followed by a unit qualifier and the quantityPackage 35573-0464-02. 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 and amphetamine sulfate extended-release 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 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release 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 35573-464
- What is NDC 35573-464?
- 35573-464 is the product NDC for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients capsule, extended release, listed with the FDA by Burel Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate.
- What is the active ingredient?
- Dextroamphetamine saccharate, Dextroamphetamine sulfate, Amphetamine aspartate monohydrate, Amphetamine sulfate.
- Who is the labeler?
- Burel Pharmaceuticals, LLC, NDC labeler code 35573. 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 Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate?
- 91 other product NDCs are listed under this name. See all Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, 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 Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under ANDA 212037
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.