Prescription drug · ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate NDC 13107-073
Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients · Tablet · Oral · Aurolife Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-073-01 | 1310700730113107007301 | 100 TABLET in 1 BOTTLE (13107-073-01)Marketed from Nov 27, 2013 | |
| 13107-073-05 | 1310700730513107007305 | 500 TABLET in 1 BOTTLE (13107-073-05)Marketed from Nov 27, 2013 | |
| 13107-073-25 | 1310700732513107007325 | 250 TABLET in 1 BOTTLE (13107-073-25)Marketed from Nov 27, 2013 | |
| 13107-073-50 | 1310700735013107007350 | 50 TABLET in 1 BOTTLE (13107-073-50)Marketed from Nov 27, 2013 | |
| 13107-073-99 | 1310700739913107007399 | 1000 TABLET in 1 BOTTLE (13107-073-99)Marketed from Nov 27, 2013 |
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 monohydrate — 5 mg/1Dextroamphetamine sulfate — 5 mg/1Amphetamine sulfate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurolife Pharma, LLCNDC labeler code 13107
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202424
- 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 13107-073_44a9eb77-0896-4b62-9953-7121d97d6ffdSPL ID 44a9eb77-0896-4b62-9953-7121d97d6ffdSPL set ID a582d57f-d191-4ca5-b105-585b2d8a0e3eRxCUI 541363, 541878, 541892, 577957, 577961, 687043, 1009145UNII G83415V073, JJ768O327N, 6DPV8NK46S, O1ZPV620O4UPC 0313107070013, 0313107068010, 0313107071010, 0313107074011, 0313107073014
- 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
N413107007301followed by a unit qualifier and the quantityPackage 13107-0073-01. 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed salts of single entity amphetamine product) 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…
Excerpt only. Read the full label for complete information.
About NDC 13107-073
- What is NDC 13107-073?
- 13107-073 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 Aurolife Pharma, LLC. It has 5 package NDCs, 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 monohydrate, Dextroamphetamine sulfate, Amphetamine sulfate.
- Who is the labeler?
- Aurolife Pharma, LLC, NDC labeler code 13107. 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 202424
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.