NDC codes

FDA NDC Directory
Product NDC (as listed)0480-3315Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00480-3315Add 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
0480-3315-650048033156530 BLISTER PACK in 1 CARTON (0480-3315-65) / 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 — 3.1 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
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 0480-3315_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

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

N400480331565 followed by a unit qualifier and the quantity

Package 00480-3315-65. 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 . 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 0480-3315

What is NDC 0480-3315?
0480-3315 is the product NDC for Amphetamine, Amphetamine 3.1 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AmphetamineAmphetamine 6.3 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals, Inc.0480-331600480-3316-65
AmphetamineAmphetamine 9.4 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals, Inc.0480-331700480-3317-65
AmphetamineAmphetamine 12.5 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals, Inc.0480-331800480-3318-65
AmphetamineAmphetamine 15.7 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals, Inc.0480-331900480-3319-65
AmphetamineAmphetamine 18.8 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals, Inc.0480-332000480-3320-65

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
ProductStrengthForm · routeLabelerProduct NDC
AmphetamineAmphetamine 6.3 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals, Inc.0480-3316
AmphetamineAmphetamine 9.4 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals, Inc.0480-3317
AmphetamineAmphetamine 12.5 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals, Inc.0480-3318
AmphetamineAmphetamine 15.7 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals, Inc.0480-3319
AmphetamineAmphetamine 18.8 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals, Inc.0480-3320

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