NDC codes

FDA NDC Directory
Product NDC (as listed)13107-036Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13107-0036Add 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
13107-036-011310700360113107003601100 TABLET in 1 BOTTLE (13107-036-01)Marketed from Jul 31, 2013
13107-036-50131070036501310700365050 TABLET in 1 BOTTLE (13107-036-50)Marketed from Jul 31, 2013
13107-036-9913107003699131070036991000 TABLET in 1 BOTTLE (13107-036-99)Marketed from Jul 31, 2013

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)
Dextroamphetamine Sulfate
Generic name (nonproprietary)
dextroamphetamine sulfate
Active ingredients
Dextroamphetamine sulfate — 10 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 202893
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 13107-036_9f989dfd-e290-448a-a66f-b22eaf61c9fdSPL ID 9f989dfd-e290-448a-a66f-b22eaf61c9fdSPL set ID 24163442-dd03-4066-a6ed-eb7e292b700bRxCUI 884385, 884386UNII JJ768O327N

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

N413107003601 followed by a unit qualifier and the quantity

Package 13107-0036-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 13107-036

What is NDC 13107-036?
13107-036 is the product NDC for Dextroamphetamine Sulfate, Dextroamphetamine sulfate 10 mg/1 tablet, listed with the FDA by Aurolife Pharma, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dextroamphetamine Sulfate.
What is the active ingredient?
Dextroamphetamine 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 Dextroamphetamine Sulfate?
38 other product NDCs are listed under this name. See all Dextroamphetamine 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 Dextroamphetamine Sulfate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dextroamphetamine SulfateDextroamphetamine sulfate 5 mg/1TabletOralCranbury Pharmaceuticals, LLC27808-08927808-0089-01
Dextroamphetamine SulfateDextroamphetamine sulfate 10 mg/1TabletOralCranbury Pharmaceuticals, LLC27808-09027808-0090-01
Dextroamphetamine SulfateDextroamphetamine sulfate 2.5 mg/1TabletOralWinder Laboratories LLC75826-12075826-0120-1075826-0120-30
Dextroamphetamine SulfateDextroamphetamine sulfate 5 mg/1TabletOralWinder Laboratories LLC75826-12175826-0121-1075826-0121-30
Dextroamphetamine SulfateDextroamphetamine sulfate 7.5 mg/1TabletOralWinder Laboratories LLC75826-12275826-0122-1075826-0122-30
Dextroamphetamine SulfateDextroamphetamine sulfate 10 mg/1TabletOralWinder Laboratories LLC75826-12375826-0123-1075826-0123-30
Dextroamphetamine SulfateDextroamphetamine sulfate 15 mg/1TabletOralWinder Laboratories LLC75826-12475826-0124-1075826-0124-30
Dextroamphetamine SulfateDextroamphetamine sulfate 20 mg/1TabletOralWinder Laboratories LLC75826-12575826-0125-1075826-0125-30
Dextroamphetamine SulfateDextroamphetamine sulfate 30 mg/1TabletOralWinder Laboratories LLC75826-12675826-0126-1075826-0126-30
Dextroamphetamine SulfateDextroamphetamine sulfate 15 mg/1TabletOralWilshire Pharmaceuticals, Inc.52536-51552536-0515-03

All 39 Dextroamphetamine Sulfate NDCs

Other NDCs under ANDA 202893

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

FDA NDC Directory listings under ANDA 202893
ProductStrengthForm · routeLabelerProduct NDC
Dextroamphetamine SulfateDextroamphetamine sulfate 5 mg/1TabletOralAurolife Pharma, LLC13107-035

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