NDC codes

FDA NDC Directory
Product NDC (as listed)57664-047Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57664-0047Add 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
57664-047-8857664004788100 CAPSULE in 1 BOTTLE (57664-047-88)Marketed from Aug 25, 2023

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)
Lisdexamfetamine Dimesylate
Generic name (nonproprietary)
lisdexamfetamine dimesylate
Active ingredients
Lisdexamfetamine dimesylate — 20 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 57664
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214484
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 57664-047_560b4c9e-9cce-4717-e063-6294a90a58c9SPL ID 560b4c9e-9cce-4717-e063-6294a90a58c9SPL set ID da3148af-f9b6-4725-adae-3595b4c7dc4bRxCUI 854830, 854834, 854838, 854842, 854846, 854850, 1593856, 1871456, 1871460, 1871462, 1871464, 1871466, 1871468UNII SJT761GEGS

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

N457664004788 followed by a unit qualifier and the quantity

Package 57664-0047-88. 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)

Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1 )] Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2 )] . Limitations of Use: The use of lisdexamfetamine dimesylate 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 [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]. …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57664-047

What is NDC 57664-047?
57664-047 is the product NDC for Lisdexamfetamine Dimesylate, Lisdexamfetamine dimesylate 20 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. 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 20 mg/1CapsuleOralAmerican Health Packaging60687-89660687-0896-21
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 50 mg/1CapsuleOralAmerican Health Packaging60687-92960687-0929-21
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 60 mg/1CapsuleOralAmerican Health Packaging60687-94060687-0940-21
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 70 mg/1CapsuleOralAmerican Health Packaging60687-95160687-0951-21
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 10 mg/1CapsuleOralSandoz Inc0781-229900781-2299-01
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 20 mg/1CapsuleOralSandoz Inc0781-247600781-2476-01
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 214484

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

FDA NDC Directory listings under ANDA 214484
ProductStrengthForm · routeLabelerProduct NDC
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 10 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-046
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 30 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-048
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 40 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-049
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 50 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-050
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 60 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-051
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 70 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-052

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