Prescription drug · NDA
Arynta (Lisdexamfetamine dimesylate oral) NDC 24338-103
Lisdexamfetamine dimesylate 10 mg/mL · Solution · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24338-103-01 | 24338010301 | 1 BOTTLE in 1 CARTON (24338-103-01) / 30 mL in 1 BOTTLEMarketed from Mar 20, 2026 |
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)
- Arynta
- Generic name (nonproprietary)
- lisdexamfetamine dimesylate oral
- Active ingredients
- Lisdexamfetamine dimesylate — 10 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Azurity Pharmaceuticals, Inc.NDC labeler code 24338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219847
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 24338-103_ac355447-df74-4bb1-b0b6-1869a4846309SPL ID ac355447-df74-4bb1-b0b6-1869a4846309SPL set ID 71cdfc97-96af-4378-a44a-6d5d77e7d6b7RxCUI 2726048, 2726055UNII SJT761GEGSUPC 0324338019016, 0324338103012, 0324338109014, 0324338160015
- 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
N424338010301followed by a unit qualifier and the quantityPackage 24338-0103-01. 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)
ARYNTA is 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 ARYNTA 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 )] . ARYNTA is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for w…
Excerpt only. Read the full label for complete information.
About NDC 24338-103
- What is NDC 24338-103?
- 24338-103 is the product NDC for Arynta (lisdexamfetamine dimesylate oral), Lisdexamfetamine dimesylate 10 mg/mL solution, listed with the FDA by Azurity Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Arynta (Lisdexamfetamine dimesylate oral).
- What is the active ingredient?
- Lisdexamfetamine dimesylate.
- Who is the labeler?
- Azurity Pharmaceuticals, Inc., NDC labeler code 24338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Arynta?
- 4 other product NDCs are listed under this name. See all Arynta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Arynta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aryntalisdexamfetamine dimesylate oral | Lisdexamfetamine dimesylate 10 mg/mL | SolutionOral | Azurity Pharmaceuticals, Inc. | 24338-019 | 24338-0019-01 |
| Aryntalisdexamfetamine dimesylate oral | Lisdexamfetamine dimesylate 10 mg/mL | SolutionOral | Azurity Pharmaceuticals, Inc. | 24338-109 | 24338-0109-01 |
| Aryntalisdexamfetamine dimesylate oral | Lisdexamfetamine dimesylate 10 mg/mL | SolutionOral | Azurity Pharmaceuticals, Inc. | 24338-160 | 24338-0160-01 |
| Aryntalisdexamfetamine dimesylate oral | Lisdexamfetamine dimesylate 10 mg/mL | SolutionOral | Azurity Pharmaceuticals, Inc. | 24338-162 | 24338-0162-01 |
Other NDCs under NDA 219847
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Aryntalisdexamfetamine dimesylate oral | Lisdexamfetamine dimesylate 10 mg/mL | SolutionOral | Azurity Pharmaceuticals, Inc. | 24338-019 |
| Aryntalisdexamfetamine dimesylate oral | Lisdexamfetamine dimesylate 10 mg/mL | SolutionOral | Azurity Pharmaceuticals, Inc. | 24338-109 |
| Aryntalisdexamfetamine dimesylate oral | Lisdexamfetamine dimesylate 10 mg/mL | SolutionOral | Azurity Pharmaceuticals, Inc. | 24338-160 |
| Aryntalisdexamfetamine dimesylate oral | Lisdexamfetamine dimesylate 10 mg/mL | SolutionOral | Azurity Pharmaceuticals, Inc. | 24338-162 |