NDC codes

FDA NDC Directory
Product NDC (as listed)54092-468Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54092-0468Add 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
54092-468-0154092046801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-468-01)Marketed from Jun 20, 2017

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)
Mydayis
Generic name (nonproprietary)
dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate
Active ingredients
Dextroamphetamine sulfate — 3.125 mg/1Dextroamphetamine saccharate — 3.125 mg/1Amphetamine aspartate monohydrate — 3.125 mg/1Amphetamine sulfate — 3.125 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022063
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 54092-468_13a2ab7d-af84-4e46-a58f-9e9c17b5c0e5SPL ID 13a2ab7d-af84-4e46-a58f-9e9c17b5c0e5SPL set ID 141a7970-3f06-44ea-9ab7-aeece2c085fcRxCUI 1927610, 1927616, 1927617, 1927619, 1927630, 1927632, 1927637, 1927639UNII O1ZPV620O4, G83415V073, 6DPV8NK46S, JJ768O327N

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

N454092046801 followed by a unit qualifier and the quantity

Package 54092-0468-01. 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)

MYDAYIS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14) ] . MYDAYIS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. ( 1 ) Limitations of Use : Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite. ( 8.4 ) Limitations of Use : Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022063

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

FDA NDC Directory listings under NDA 022063
ProductStrengthForm · routeLabelerProduct NDC
Mydayisdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfateDextroamphetamine sulfate 9.375 mg/1 + 3 more ingredientsCapsule, Extended releaseOralTakeda Pharmaceuticals America, Inc.54092-474
Mydayisdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfateDextroamphetamine sulfate 6.25 mg/1 + 3 more ingredientsCapsule, Extended releaseOralTakeda Pharmaceuticals America, Inc.54092-471
Mydayisdextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfateDextroamphetamine sulfate 12.5 mg/1 + 3 more ingredientsCapsule, Extended releaseOralTakeda Pharmaceuticals America, Inc.54092-477

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Mydayis NDC 54092-468 | Med-Code