NDC codes

FDA NDC Directory
Product NDC (as listed)64850-556Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64850-0556Add 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
64850-556-0164850055601100 CAPSULE in 1 BOTTLE (64850-556-01)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 — 70 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
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 64850-556_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

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

N464850055601 followed by a unit qualifier and the quantity

Package 64850-0556-01. 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 . 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 64850-556

What is NDC 64850-556?
64850-556 is the product NDC for Lisdexamfetamine Dimesylate, Lisdexamfetamine dimesylate 70 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
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 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
ProductStrengthForm · routeLabelerProduct NDC
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 10 mg/1CapsuleOralElite Laboratories, Inc.64850-550
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 40 mg/1CapsuleOralElite Laboratories, Inc.64850-553
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 20 mg/1CapsuleOralElite Laboratories, Inc.64850-551
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 30 mg/1CapsuleOralElite Laboratories, Inc.64850-552
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 50 mg/1CapsuleOralElite Laboratories, Inc.64850-554
Lisdexamfetamine DimesylateLisdexamfetamine dimesylate 60 mg/1CapsuleOralElite Laboratories, Inc.64850-555

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