NDC codes

FDA NDC Directory
Product NDC (as listed)54092-387Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54092-0387Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
54092-387-0154092038701100 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

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

N454092038701 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021303

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021303
ProductStrengthForm · routeLabelerProduct NDC
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 2.5 mg/1 + 3 more ingredientsCapsule, Extended releaseOralSandoz Inc0781-2335
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 3.75 mg/1 + 3 more ingredientsCapsule, Extended releaseOralSandoz Inc0781-2343
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 5 mg/1 + 3 more ingredientsCapsule, Extended releaseOralSandoz Inc0781-2352
Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartateDextroamphetamine sulfate 7.5 mg/1 + 3 more ingredientsCapsule, Extended releaseOralTakeda Pharmaceuticals America, Inc.54092-391
Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartateDextroamphetamine sulfate 3.75 mg/1 + 3 more ingredientsCapsule, Extended releaseOralTakeda Pharmaceuticals America, Inc.54092-385
Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartateDextroamphetamine sulfate 6.25 mg/1 + 3 more ingredientsCapsule, Extended releaseOralTakeda Pharmaceuticals America, Inc.54092-389
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 6.25 mg/1 + 3 more ingredientsCapsule, Extended releaseOralSandoz Inc0781-2368
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 7.5 mg/1 + 3 more ingredientsCapsule, Extended releaseOralSandoz Inc0781-2371
Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartateDextroamphetamine sulfate 2.5 mg/1 + 3 more ingredientsCapsule, Extended releaseOralTakeda Pharmaceuticals America, Inc.54092-383
Adderall XRdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartateDextroamphetamine sulfate 1.25 mg/1 + 3 more ingredientsCapsule, Extended releaseOralTakeda Pharmaceuticals America, Inc.54092-381
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 2.5 mg/1 + 3 more ingredientsCapsule, Extended releaseOralPrasco Laboratories66993-595
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 1.25 mg/1 + 3 more ingredientsCapsule, Extended releaseOralPrasco Laboratories66993-594
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 6.25 mg/1 + 3 more ingredientsCapsule, Extended releaseOralPrasco Laboratories66993-598
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 3.75 mg/1 + 3 more ingredientsCapsule, Extended releaseOralPrasco Laboratories66993-596
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 5 mg/1 + 3 more ingredientsCapsule, Extended releaseOralPrasco Laboratories66993-597
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 7.5 mg/1 + 3 more ingredientsCapsule, Extended releaseOralPrasco Laboratories66993-599
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateDextroamphetamine saccharate 1.25 mg/1 + 3 more ingredientsCapsule, Extended releaseOralSandoz Inc0781-2329

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