NDC 42858-722

NDC codes

FDA NDC Directory

Product NDC (as listed)42858-722Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42858-0722Add 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
42858-722-01	42858072201	100 TABLET in 1 BOTTLE (42858-722-01)Marketed from Sep 9, 2021

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 Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Generic name (nonproprietary): dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Active ingredients: Dextroamphetamine saccharate — 1.875 mg/1Amphetamine aspartate monohydrate — 1.875 mg/1Dextroamphetamine sulfate — 1.875 mg/1Amphetamine sulfate — 1.875 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Rhodes Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213111
Marketing start: Sep 9, 2021
Listing expires: Dec 31, 2027
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 42858-722_124f93d9-2c76-480c-82f5-43a6d9fdb87bSPL ID 124f93d9-2c76-480c-82f5-43a6d9fdb87bSPL set ID ef3590cc-49ae-44f7-85a9-7c11f58d467eRxCUI 541363, 541878, 541892, 577957, 577961, 687043, 1009145UNII JJ768O327N, O1ZPV620O4, 6DPV8NK46S, G83415V073UPC 0342858725019
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

N442858072201 followed by a unit qualifier and the quantity

Package 42858-0722-01. 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 May 13, 2026. 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)

Other NDCs under ANDA 213111

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

FDA NDC Directory listings under ANDA 213111
Product	Strength	Form · route	Labeler	Product NDC
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients	TabletOral	Rhodes Pharmaceuticals LLC	42858-721
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients	TabletOral	Rhodes Pharmaceuticals LLC	42858-726
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients	TabletOral	Rhodes Pharmaceuticals LLC	42858-723
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients	TabletOral	Rhodes Pharmaceuticals LLC	42858-724
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients	TabletOral	Rhodes Pharmaceuticals LLC	42858-725
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients	TabletOral	Rhodes Pharmaceuticals LLC	42858-727

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate NDC 42858-722