NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1081Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1081Add 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
71335-1081-17133510810160 TABLET in 1 BOTTLE (71335-1081-1)Marketed from Jan 14, 2019
71335-1081-27133510810290 TABLET in 1 BOTTLE (71335-1081-2)Marketed from Oct 31, 2024
71335-1081-37133510810330 TABLET in 1 BOTTLE (71335-1081-3)Marketed from Feb 25, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Dextroamphetamine Sulfate and Amphetamine Sulfate
Generic name (nonproprietary)
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Active ingredients
Dextroamphetamine saccharate — 7.5 mg/1Amphetamine aspartate monohydrate — 7.5 mg/1Dextroamphetamine sulfate — 7.5 mg/1Amphetamine sulfate — 7.5 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202424
Marketing start
Listing expires
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 71335-1081_d0decb1e-6b20-4d85-a84f-5d6b3ddfc07dSPL ID d0decb1e-6b20-4d85-a84f-5d6b3ddfc07dSPL set ID ff1e5518-0aa6-4bc9-bc87-8a6a124bc95aRxCUI 541363UNII G83415V073, O1ZPV620O4, JJ768O327N, 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

N471335108101 followed by a unit qualifier and the quantity

Package 71335-1081-01. 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be be…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202424

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

FDA NDC Directory listings under ANDA 202424
ProductStrengthForm · routeLabelerProduct NDC
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 2.5 mg/1 + 3 more ingredientsTabletOralAurolife Pharma, LLC13107-070
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 1.25 mg/1 + 3 more ingredientsTabletOralAurolife Pharma, LLC13107-068
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 1.875 mg/1 + 3 more ingredientsTabletOralAurolife Pharma, LLC13107-069
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 7.5 mg/1 + 3 more ingredientsTabletOralAurolife Pharma, LLC13107-074
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 3.125 mg/1 + 3 more ingredientsTabletOralAurolife Pharma, LLC13107-071
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 3.75 mg/1 + 3 more ingredientsTabletOralAurolife Pharma, LLC13107-072
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 5 mg/1 + 3 more ingredientsTabletOralAurolife Pharma, LLC13107-073
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 1.875 mg/1 + 3 more ingredientsTabletOralNorthStar RxLLC16714-949
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 1.25 mg/1 + 3 more ingredientsTabletOralNorthStar RxLLC16714-948
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 2.5 mg/1 + 3 more ingredientsTabletOralNorthStar RxLLC16714-950
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 3.75 mg/1 + 3 more ingredientsTabletOralNorthStar RxLLC16714-952
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine saccharate 5 mg/1 + 3 more ingredientsTabletOralNorthStar RxLLC16714-953

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