What is NDC 0480-3685?

0480-3685 is the product NDC for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, Dextroamphetamine saccharate 9.375 mg/1 + 3 more ingredients capsule, extended release, 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 0480-3685

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-3685Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-3685Add 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
0480-3685-01	00480368501	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3685-01)Marketed from Oct 10, 2023

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): dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Generic name (nonproprietary): dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Active ingredients: Dextroamphetamine saccharate — 9.375 mg/1Amphetamine aspartate monohydrate — 9.375 mg/1Dextroamphetamine sulfate — 9.375 mg/1Amphetamine sulfate — 9.375 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Teva Pharmaceuticals, Inc.NDC labeler code 0480
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210876
Marketing start: Oct 10, 2023
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 0480-3685_2994aa65-1449-499f-9a9e-cc701dcd4c27SPL ID 2994aa65-1449-499f-9a9e-cc701dcd4c27SPL set ID 5e84ef60-3050-40d9-9f14-66b85d289e17RxCUI 1927610, 1927617, 1927630, 1927637UNII G83415V073, JJ768O327N, 6DPV8NK46S, O1ZPV620O4UPC 0304803683010, 0304803684017, 0304803686011, 0304803685014
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

N400480368501 followed by a unit qualifier and the quantity

Package 00480-3685-01. 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 Jun 1, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies ( 14 )]. Limitations of Use : Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see Use in Specific Populations ( 8.4 )]. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0480-3685

What is NDC 0480-3685?: 0480-3685 is the product NDC for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, Dextroamphetamine saccharate 9.375 mg/1 + 3 more ingredients capsule, extended release, 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?: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate.
What is the active ingredient?: Dextroamphetamine saccharate, Amphetamine aspartate monohydrate, Dextroamphetamine sulfate, Amphetamine sulfate.
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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 210876

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

FDA NDC Directory listings under ANDA 210876
Product	Strength	Form · route	Labeler	Product NDC
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate 6.25 mg/1 + 3 more ingredients	Capsule, Extended releaseOral	Teva Pharmaceuticals, Inc.	0480-3684
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate 12.5 mg/1 + 3 more ingredients	Capsule, Extended releaseOral	Teva Pharmaceuticals, Inc.	0480-3686
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients	Capsule, Extended releaseOral	Teva Pharmaceuticals, Inc.	0480-3683

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate NDC 0480-3685