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
13107-036-0113107003601100 TABLET in 1 BOTTLE (13107-036-01)Marketed from Jul 31, 2013
13107-036-501310700365050 TABLET in 1 BOTTLE (13107-036-50)Marketed from Jul 31, 2013
13107-036-99131070036991000 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
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)

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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