NDC codes

FDA NDC Directory
Product NDC (as listed)13107-259Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13107-0259Add 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
13107-259-0113107025901100 TABLET in 1 BOTTLE (13107-259-01)Marketed from Jan 31, 2019

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)
Amphetamine Sulfate
Generic name (nonproprietary)
amphetamine sulfate
Active ingredients
Amphetamine sulfate — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Aurolife Pharma, LLCNDC labeler code 13107
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211639
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 13107-259_c1856faf-f91e-4fd4-b5af-21daec941818SPL ID c1856faf-f91e-4fd4-b5af-21daec941818SPL set ID 20735c2e-6304-425f-a4e4-584f6f90d6a0RxCUI 884655, 1600695UNII 6DPV8NK46S

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

N413107025901 followed by a unit qualifier and the quantity

Package 13107-0259-01. 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)

INDICATIONS AND USAGE Amphetamine Sulfate Tablets USP are indicated for: Narcolepsy Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disabilit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13107-259

What is NDC 13107-259?
13107-259 is the product NDC for Amphetamine Sulfate, Amphetamine sulfate 5 mg/1 tablet, listed with the FDA by Aurolife Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amphetamine Sulfate.
What is the active ingredient?
Amphetamine sulfate.
Who is the labeler?
Aurolife Pharma, LLC, NDC labeler code 13107. 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 Sulfate?
32 other product NDCs are listed under this name. See all Amphetamine Sulfate 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 Sulfate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amphetamine SulfateAmphetamine sulfate 5 mg/1TabletOralAmici Pharma, Inc.69292-10669292-0106-01
Amphetamine Sulfateamphetamine sulfate tabletsAmphetamine sulfate 10 mg/1TabletOralAmici Pharma, Inc.69292-10769292-0107-01
Amphetamine SulfateAmphetamine sulfate 5 mg/1TabletOralSpecGx LLC0406-121900406-1219-01
Amphetamine SulfateAmphetamine sulfate 10 mg/1TabletOralSpecGx LLC0406-122000406-1220-01
Amphetamine SulfateAmphetamine sulfate 5 mg/1TabletOralEpic Pharma LLC42806-02942806-0029-01
Amphetamine SulfateAmphetamine sulfate 10 mg/1TabletOralEpic Pharma LLC42806-03042806-0030-01
Amphetamine SulfateAmphetamine sulfate 10 mg/1TabletOralBryant Ranch Prepack63629-111463629-1114-01
Amphetamine SulfateAmphetamine sulfate 5 mg/1TabletOralBryant Ranch Prepack63629-111563629-1115-01
Amphetamine SulfateAmphetamine sulfate 10 mg/1TabletOralBryant Ranch Prepack63629-207863629-2078-01
Amphetamine SulfateAmphetamine sulfate 5 mg/1TabletOralBryant Ranch Prepack63629-207963629-2079-01

All 33 Amphetamine Sulfate NDCs

Other NDCs under ANDA 211639

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

FDA NDC Directory listings under ANDA 211639
ProductStrengthForm · routeLabelerProduct NDC
Amphetamine SulfateAmphetamine sulfate 10 mg/1TabletOralAurolife Pharma, LLC13107-260

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