Prescription drug · NDA
Adderall XR NDC 54092-387
Dextroamphetamine sulfate 5 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54092-387-01 | 54092038701 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-387-01)Marketed from May 22, 2002 |
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)
- Adderall XRSuffix: XR
- Generic name (nonproprietary)
- dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate
- Active ingredients
- Dextroamphetamine sulfate — 5 mg/1Dextroamphetamine saccharate — 5 mg/1Amphetamine aspartate monohydrate — 5 mg/1Amphetamine sulfate — 5 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021303
- 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 54092-387_38ac432b-672e-4dd1-8af5-bea373aa5f3fSPL ID 38ac432b-672e-4dd1-8af5-bea373aa5f3fSPL set ID aff45863-ffe1-4d4f-8acf-c7081512a6c0RxCUI 861221, 861222, 861223, 861224, 861225, 861226, 861227, 861228, 861232, 861233, 861237, 861238UNII JJ768O327N, O1ZPV620O4, 6DPV8NK46S, G83415V073UPC 0354092387014, 0354092391011
- 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
N454092038701followed by a unit qualifier and the quantityPackage 54092-0387-01. 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)
ADDERALL XR, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. ( 1 ) Limitations of Use The use of ADDERALL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. ( 5.5 , 8.4 ) 1.1 Attention Deficit Hyperactivity Disorder ADDERALL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Limitations of Use The use of ADDERALL XR is not recommend…
Excerpt only. Read the full label for complete information.
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 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 5 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2352 |
| 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 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 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 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 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 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-381 |
| 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 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Prasco Laboratories | 66993-594 |
| 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 |
| 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 | Prasco Laboratories | 66993-597 |
| 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 1.25 mg/1 + 3 more ingredients | Capsule, Extended releaseOral | Sandoz Inc | 0781-2329 |