NDC codes

FDA NDC Directory
Product NDC (as listed)0406-5129Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00406-5129Add 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
0406-5129-010040651290100406512901100 TABLET, CHEWABLE in 1 BOTTLE (0406-5129-01)Marketed from Dec 17, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Lisdexamfetamine Dimesylate
Generic name (nonproprietary)
lisdexamfetamine dimesylate
Active ingredients
Lisdexamfetamine dimesylate — 60 mg/1
Dosage form
Tablet, Chewable
Route
Oral
Labeler
SpecGx LLCNDC labeler code 0406
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218850
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 0406-5129_b8fbbe5c-6972-454b-9738-4f4d8b2a7264SPL ID b8fbbe5c-6972-454b-9738-4f4d8b2a7264

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

N400406512901 followed by a unit qualifier and the quantity

Package 00406-5129-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0406-5129

What is NDC 0406-5129?
0406-5129 is the product NDC for Lisdexamfetamine Dimesylate, Lisdexamfetamine dimesylate 60 mg/1 tablet, chewable, listed with the FDA by SpecGx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Lisdexamfetamine Dimesylate.
What is the active ingredient?
Lisdexamfetamine dimesylate.
Who is the labeler?
SpecGx LLC, NDC labeler code 0406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lisdexamfetamine Dimesylate?
159 other product NDCs are listed under this name. See all Lisdexamfetamine Dimesylate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lisdexamfetamine Dimesylate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 30 mg/1CapsuleOralAmerican Health Packaging60687-90760687-0907-21
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 40 mg/1CapsuleOralAmerican Health Packaging60687-91860687-0918-21
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 70 mg/1CapsuleOralAmerican Health Packaging60687-95160687-0951-21
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 20 mg/1CapsuleOralAmerican Health Packaging60687-89660687-0896-21
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 50 mg/1CapsuleOralAmerican Health Packaging60687-92960687-0929-21
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 60 mg/1CapsuleOralAmerican Health Packaging60687-94060687-0940-21
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 40 mg/1CapsuleOralSandoz Inc0781-247800781-2478-01
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 50 mg/1CapsuleOralSandoz Inc0781-247900781-2479-01
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 60 mg/1CapsuleOralSandoz Inc0781-248000781-2480-01
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 70 mg/1CapsuleOralSandoz Inc0781-248100781-2481-01

All 160 Lisdexamfetamine Dimesylate NDCs

Other NDCs under ANDA 218850

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

FDA NDC Directory listings under ANDA 218850
ProductStrengthForm · routeLabelerProduct NDC
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 10 mg/1Tablet, ChewableOralSpecGx LLC0406-5124
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 20 mg/1Tablet, ChewableOralSpecGx LLC0406-5125
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 30 mg/1Tablet, ChewableOralSpecGx LLC0406-5126
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 40 mg/1Tablet, ChewableOralSpecGx LLC0406-5127
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 50 mg/1Tablet, ChewableOralSpecGx LLC0406-5128

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