NDC codes

FDA NDC Directory
Product NDC (as listed)0527-4663Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00527-4663Add 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
0527-4663-370052746633700527466337100 CAPSULE in 1 BOTTLE (0527-4663-37)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 — 30 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Lannett Company, LLCNDC labeler code 0527
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215802
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 0527-4663_164b5658-3c14-44f5-b10a-839909184984SPL ID 164b5658-3c14-44f5-b10a-839909184984

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

N400527466337 followed by a unit qualifier and the quantity

Package 00527-4663-37. 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 0527-4663

What is NDC 0527-4663?
0527-4663 is the product NDC for Lisdexamfetamine Dimesylate, Lisdexamfetamine dimesylate 30 mg/1 capsule, listed with the FDA by Lannett Company, 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?
Lannett Company, LLC, NDC labeler code 0527. 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 20 mg/1CapsuleOralSandoz Inc0781-247600781-2476-01
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 10 mg/1CapsuleOralSandoz Inc0781-229900781-2299-01
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 30 mg/1CapsuleOralSandoz Inc0781-247700781-2477-01
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 40 mg/1CapsuleOralSandoz Inc0781-247800781-2478-01

All 160 Lisdexamfetamine Dimesylate NDCs

Other NDCs under ANDA 215802

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

FDA NDC Directory listings under ANDA 215802
ProductStrengthForm · routeLabelerProduct NDC
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 10 mg/1CapsuleOralLannett Company, LLC0527-4661
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 20 mg/1CapsuleOralLannett Company, LLC0527-4662
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 40 mg/1CapsuleOralLannett Company, LLC0527-4664
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 50 mg/1CapsuleOralLannett Company, LLC0527-4665
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 60 mg/1CapsuleOralLannett Company, LLC0527-4666
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 70 mg/1CapsuleOralLannett Company, LLC0527-4667

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