Prescription drug · ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate NDC 71335-1249
Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1249-1 | 71335124901 | 60 TABLET in 1 BOTTLE (71335-1249-1)Marketed from May 17, 2024 | |
| 71335-1249-2 | 71335124902 | 30 TABLET in 1 BOTTLE (71335-1249-2)Marketed from Jun 17, 2019 | |
| 71335-1249-3 | 71335124903 | 90 TABLET in 1 BOTTLE (71335-1249-3)Marketed from May 17, 2024 | |
| 71335-1249-4 | 71335124904 | 120 TABLET in 1 BOTTLE (71335-1249-4)Marketed from May 17, 2024 | |
| 71335-1249-5 | 71335124905 | 18 TABLET in 1 BOTTLE (71335-1249-5)Marketed from May 17, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2.5 mg/1Amphetamine aspartate monohydrate — 2.5 mg/1Dextroamphetamine sulfate — 2.5 mg/1Amphetamine sulfate — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040439
- 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 71335-1249_f73dc72b-3165-408a-9f75-14cb836bd48bSPL ID f73dc72b-3165-408a-9f75-14cb836bd48bSPL set ID b8ed12f7-7532-4e43-9fa9-d5a217b5661dRxCUI 541892UNII G83415V073, O1ZPV620O4, JJ768O327N, 6DPV8NK46S
- 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
N471335124901followed by a unit qualifier and the quantityPackage 71335-1249-01. 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 a single entity amphetamine product) is 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., sch…
Excerpt only. Read the full label for complete information.
About NDC 71335-1249
- What is NDC 71335-1249?
- 71335-1249 is the product NDC for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, 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, Amphetamine aspartate monohydrate, Dextroamphetamine sulfate, Amphetamine sulfate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 040439
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.