What is NDC 0480-3319?

0480-3319 is the product NDC for Amphetamine, Amphetamine 15.7 mg/1 tablet, orally disintegrating, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amphetamine?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amphetamine NDC 0480-3319 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-3319Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-3319Add 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
0480-3319-65	00480331965	30 BLISTER PACK in 1 CARTON (0480-3319-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 8, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Amphetamine
Generic name (nonproprietary): amphetamine
Active ingredients: Amphetamine — 15.7 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Teva Pharmaceuticals, Inc.NDC labeler code 0480
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209253
Marketing start: Dec 8, 2025
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 0480-3319_074770c9-d04b-4ad5-b346-76f9c121a44dSPL ID 074770c9-d04b-4ad5-b346-76f9c121a44dSPL set ID 243e88e7-6621-47e9-8d5c-3f79bcb088bbRxCUI 1739803, 1739813, 1739819, 1739825, 1739831, 1739837UNII CK833KGX7E
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

N400480331965 followed by a unit qualifier and the quantity

Package 00480-3319-65. 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 Sep 1, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Amphetamine extended-release orally disintegrating tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies ( 14 )] . Limitations of Use The use of amphetamine extended-release orally disintegrating tablets 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 )] . Amphetamine extended-release orally disintegrating tablets are …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0480-3319

What is NDC 0480-3319?: 0480-3319 is the product NDC for Amphetamine, Amphetamine 15.7 mg/1 tablet, orally disintegrating, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amphetamine.
What is the active ingredient?: Amphetamine.
Who is the labeler?: Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amphetamine?: 5 other product NDCs are listed under this name. See all Amphetamine 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 Amphetamine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amphetamine	Amphetamine 3.1 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals, Inc.	0480-3315	00480-3315-65
Amphetamine	Amphetamine 6.3 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals, Inc.	0480-3316	00480-3316-65
Amphetamine	Amphetamine 9.4 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals, Inc.	0480-3317	00480-3317-65
Amphetamine	Amphetamine 12.5 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals, Inc.	0480-3318	00480-3318-65
Amphetamine	Amphetamine 18.8 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals, Inc.	0480-3320	00480-3320-65

Other NDCs under ANDA 209253

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

FDA NDC Directory listings under ANDA 209253
Product	Strength	Form · route	Labeler	Product NDC
Amphetamine	Amphetamine 3.1 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals, Inc.	0480-3315
Amphetamine	Amphetamine 6.3 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals, Inc.	0480-3316
Amphetamine	Amphetamine 9.4 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals, Inc.	0480-3317
Amphetamine	Amphetamine 12.5 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals, Inc.	0480-3318
Amphetamine	Amphetamine 18.8 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals, Inc.	0480-3320