What is NDC 57664-048?

57664-048 is the product NDC for Lisdexamfetamine Dimesylate, Lisdexamfetamine dimesylate 30 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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lisdexamfetamine Dimesylate NDC 57664-048

NDC codes

FDA NDC Directory

Product NDC (as listed)57664-048Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57664-0048Add 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 NDC	11-digit (billing)	Package	Copy
57664-048-88	57664004888	100 CAPSULE in 1 BOTTLE (57664-048-88)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 — 30 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: Aug 25, 2023
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 57664-048_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
Pharmacologic class: Central Nervous System Stimulant

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

N457664004888 followed by a unit qualifier and the quantity

Package 57664-0048-88. 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 Jul 7, 2026. 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 57664-048

What is NDC 57664-048?: 57664-048 is the product NDC for Lisdexamfetamine Dimesylate, Lisdexamfetamine dimesylate 30 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 20 mg/1	CapsuleOral	American Health Packaging	60687-896	60687-0896-21
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 30 mg/1	CapsuleOral	American Health Packaging	60687-907	60687-0907-21
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 40 mg/1	CapsuleOral	American Health Packaging	60687-918	60687-0918-21
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 50 mg/1	CapsuleOral	American Health Packaging	60687-929	60687-0929-21
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 60 mg/1	CapsuleOral	American Health Packaging	60687-940	60687-0940-21
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 70 mg/1	CapsuleOral	American Health Packaging	60687-951	60687-0951-21
Lisdexamfetamine dimesylate	Lisdexamfetamine dimesylate 10 mg/1	CapsuleOral	Sandoz Inc	0781-2299	00781-2299-01
Lisdexamfetamine dimesylate	Lisdexamfetamine dimesylate 20 mg/1	CapsuleOral	Sandoz Inc	0781-2476	00781-2476-01
Lisdexamfetamine dimesylate	Lisdexamfetamine dimesylate 30 mg/1	CapsuleOral	Sandoz Inc	0781-2477	00781-2477-01
Lisdexamfetamine dimesylate	Lisdexamfetamine dimesylate 40 mg/1	CapsuleOral	Sandoz Inc	0781-2478	00781-2478-01

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
Product	Strength	Form · route	Labeler	Product NDC
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 10 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	57664-046
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 20 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	57664-047
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 40 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	57664-049
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 50 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	57664-050
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 60 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	57664-051
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 70 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	57664-052