What is NDC 64850-553?

64850-553 is the product NDC for Lisdexamfetamine Dimesylate, Lisdexamfetamine dimesylate 40 mg/1 capsule, listed with the FDA by Elite Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Elite Laboratories, Inc., NDC labeler code 64850. 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 64850-553

NDC codes

FDA NDC Directory

Product NDC (as listed)64850-553Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64850-0553Add 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
64850-553-01	64850055301	100 CAPSULE in 1 BOTTLE (64850-553-01)Marketed from Nov 15, 2024

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 — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Elite Laboratories, Inc.NDC labeler code 64850
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218604
Marketing start: Nov 15, 2024
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 64850-553_2d33f701-8067-4a48-98cc-4e7dacaf3cc4SPL ID 2d33f701-8067-4a48-98cc-4e7dacaf3cc4SPL set ID 0e024b69-567c-4b40-9c3e-a2daec34256cRxCUI 854830, 854834, 854838, 854842, 854846, 854850, 1593856UNII SJT761GEGSUPC 0364850552011, 0364850550017, 0364850553018, 0364850556019, 0364850555012, 0364850551014, 0364850554015
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

N464850055301 followed by a unit qualifier and the quantity

Package 64850-0553-01. 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

Current FDA label (SPL), effective Jun 22, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Lisdexamfetamine dimesylate capsules 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) ] . Lisdexamfetamine dimesylate capsules are a central nervous system (CNS) stimulant indicated for the treatment of ( 1 ): Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older Moderate to severe binge eating disorder (BED) in adults Limitations of Use : The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64850-553

What is NDC 64850-553?: 64850-553 is the product NDC for Lisdexamfetamine Dimesylate, Lisdexamfetamine dimesylate 40 mg/1 capsule, listed with the FDA by Elite Laboratories, 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?: Elite Laboratories, Inc., NDC labeler code 64850. 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 218604

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

FDA NDC Directory listings under ANDA 218604
Product	Strength	Form · route	Labeler	Product NDC
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 10 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-550
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 20 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-551
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 30 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-552
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 50 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-554
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 60 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-555
Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate 70 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-556