What is NDC 42806-344?

42806-344 is the product NDC for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients tablet, listed with the FDA by Epic Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Dextroamphetamine saccharate, Amphetamine aspartate monohydrate, Dextroamphetamine sulfate, Amphetamine sulfate.

Epic Pharma, LLC, NDC labeler code 42806. 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 42806-344

NDC codes

FDA NDC Directory

Product NDC (as listed)42806-344Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42806-0344Add 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
42806-344-01	42806034401	100 TABLET in 1 BOTTLE, PLASTIC (42806-344-01)Marketed from Mar 15, 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): 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 — 5 mg/1Amphetamine aspartate monohydrate — 5 mg/1Dextroamphetamine sulfate — 5 mg/1Amphetamine sulfate — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Epic Pharma, LLCNDC labeler code 42806
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040444
Marketing start: Mar 15, 2019
Listing expires: Dec 31, 2026
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 42806-344_f11301e2-3b5d-468d-b44c-45839e7e5dfbSPL ID f11301e2-3b5d-468d-b44c-45839e7e5dfbSPL set ID 1757e132-061d-4773-89ed-fdc77f69008fRxCUI 541363, 541878, 541892, 577957, 577961UNII G83415V073, JJ768O327N, 6DPV8NK46S, O1ZPV620O4
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

N442806034401 followed by a unit qualifier and the quantity

Package 42806-0344-01. 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 Dec 4, 2023. 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42806-344

What is NDC 42806-344?: 42806-344 is the product NDC for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients tablet, listed with the FDA by Epic Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate.
What is the active ingredient?: Dextroamphetamine saccharate, Amphetamine aspartate monohydrate, Dextroamphetamine sulfate, Amphetamine sulfate.
Who is the labeler?: Epic Pharma, LLC, NDC labeler code 42806. 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, 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 040444

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

FDA NDC Directory listings under ANDA 040444
Product	Strength	Form · route	Labeler	Product NDC
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients	TabletOral	Epic Pharma, LLC	42806-341
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients	TabletOral	Epic Pharma, LLC	42806-339
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients	TabletOral	Epic Pharma, LLC	42806-343
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients	TabletOral	Epic Pharma, LLC	42806-345

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate NDC 42806-344