NDC 64850-500

NDC codes

FDA NDC Directory

Product NDC (as listed)64850-500Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64850-0500Add 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
64850-500-01	64850050001	100 TABLET in 1 BOTTLE (64850-500-01)Marketed from Dec 29, 2022
64850-500-05	64850050005	500 TABLET in 1 BOTTLE (64850-500-05)Marketed from Dec 29, 2022
64850-500-30	64850050030	30 TABLET in 1 BOTTLE (64850-500-30)Marketed from Dec 29, 2022

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 — 1.25 mg/1Amphetamine aspartate monohydrate — 1.25 mg/1Dextroamphetamine sulfate — 1.25 mg/1Amphetamine sulfate — 1.25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Elite Laboratories, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211352
Marketing start: Dec 29, 2022
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 64850-500_a41cf8e5-cb1b-488c-96b3-3bef8283d6c4SPL ID a41cf8e5-cb1b-488c-96b3-3bef8283d6c4SPL set ID e677690f-790f-4626-ad78-097cdb6ea540RxCUI 541363, 541878, 541892, 577957, 577961, 687043, 1009145UNII JJ768O327N, O1ZPV620O4, 6DPV8NK46S, G83415V073UPC 0364850502016, 0364850506014, 0364850501019, 0364850504010, 0364850500012, 0364850505017, 0364850503013
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

N464850050001 followed by a unit qualifier and the quantity

Package 64850-0500-01. 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 Jul 15, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is 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 bet…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211352

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

FDA NDC Directory listings under ANDA 211352
Product	Strength	Form · route	Labeler	Product NDC
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 1.875 mg/1 + 3 more ingredients	TabletOral	Elite Laboratories, Inc.	64850-501
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients	TabletOral	Elite Laboratories, Inc.	64850-505
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients	TabletOral	Elite Laboratories, Inc.	64850-502
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients	TabletOral	Elite Laboratories, Inc.	64850-503
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients	TabletOral	Elite Laboratories, Inc.	64850-504
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients	TabletOral	Elite Laboratories, Inc.	64850-506

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate NDC 64850-500