Prescription drug · ANDA

Lisdexamfetamine Dimesylate NDC 0406-5112

Lisdexamfetamine dimesylate 20 mg/1 · Capsule · Oral · SpecGx LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)0406-5112Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00406-5112Add 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
0406-5112-0100406511201100 CAPSULE in 1 BOTTLE (0406-5112-01)Marketed from Aug 25, 2023

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 — 20 mg/1
Dosage form
Capsule
Route
Oral
Labeler
SpecGx LLC
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211840
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 0406-5112_77f4cd3a-dca3-4995-8992-042e1dc91a00SPL ID 77f4cd3a-dca3-4995-8992-042e1dc91a00

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

N400406511201 followed by a unit qualifier and the quantity

Package 00406-5112-01. 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.

Other NDCs under ANDA 211840

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

FDA NDC Directory listings under ANDA 211840
ProductStrengthForm · routeLabelerProduct NDC
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 10 mg/1CapsuleOralSpecGx LLC0406-5111
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 30 mg/1CapsuleOralSpecGx LLC0406-5113
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 40 mg/1CapsuleOralSpecGx LLC0406-5114
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 50 mg/1CapsuleOralSpecGx LLC0406-5115
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 60 mg/1CapsuleOralSpecGx LLC0406-5116
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 70 mg/1CapsuleOralSpecGx LLC0406-5117

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Lisdexamfetamine Dimesylate NDC 0406-5112 | Med-Code