NDC codes

FDA NDC Directory
Product NDC (as listed)47781-564Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47781-0564Add 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
47781-564-014778105640147781056401100 CAPSULE in 1 BOTTLE (47781-564-01)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
Alvogen Inc.NDC labeler code 47781
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214547
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 47781-564_db02ec6b-f17f-ab22-b671-e1ddb90e017cSPL ID db02ec6b-f17f-ab22-b671-e1ddb90e017cSPL set ID 7f2dd6ee-3363-c87c-9693-ed838942556cRxCUI 854830, 854834, 854838, 854842, 854846, 854850, 1593856UNII SJT761GEGSUPC 0347781568016, 0347781564018, 0347781567019, 0347781562014, 0347781563011, 0347781565015, 0347781566012

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

N447781056401 followed by a unit qualifier and the quantity

Package 47781-0564-01. 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 )] . Limitations of Use: The use of lisdexamfetamine dimesylate capsules are 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 )] . Lisdexamfetamine dimesylate caps…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47781-564

What is NDC 47781-564?
47781-564 is the product NDC for lisdexamfetamine dimesylate, Lisdexamfetamine dimesylate 30 mg/1 capsule, listed with the FDA by Alvogen 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?
Alvogen Inc., NDC labeler code 47781. 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 40 mg/1CapsuleOralSandoz Inc0781-247800781-2478-01
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 50 mg/1CapsuleOralSandoz Inc0781-247900781-2479-01
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 60 mg/1CapsuleOralSandoz Inc0781-248000781-2480-01
Lisdexamfetamine dimesylateLisdexamfetamine dimesylate 70 mg/1CapsuleOralSandoz Inc0781-248100781-2481-01

All 160 lisdexamfetamine dimesylate NDCs

Other NDCs under ANDA 214547

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

FDA NDC Directory listings under ANDA 214547
ProductStrengthForm · routeLabelerProduct NDC
lisdexamfetamine dimesylateLisdexamfetamine dimesylate 10 mg/1CapsuleOralAlvogen Inc.47781-562
lisdexamfetamine dimesylateLisdexamfetamine dimesylate 20 mg/1CapsuleOralAlvogen Inc.47781-563
lisdexamfetamine dimesylateLisdexamfetamine dimesylate 40 mg/1CapsuleOralAlvogen Inc.47781-565
lisdexamfetamine dimesylateLisdexamfetamine dimesylate 50 mg/1CapsuleOralAlvogen Inc.47781-566
lisdexamfetamine dimesylateLisdexamfetamine dimesylate 60 mg/1CapsuleOralAlvogen Inc.47781-567
lisdexamfetamine dimesylateLisdexamfetamine dimesylate 70 mg/1CapsuleOralAlvogen Inc.47781-568
lisdexamfetamine dimesylateLisdexamfetamine dimesylate 30 mg/1CapsuleOralBryant Ranch Prepack72162-2216

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