Amphetamine Sulfate NDC 43547-457

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-457Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0457Add 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
43547-457-10	43547045710	100 TABLET in 1 BOTTLE (43547-457-10)Marketed from Apr 2, 2020

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): Amphetamine Sulfate
Generic name (nonproprietary): amphetamine sulfate
Active ingredients: Amphetamine sulfate — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Solco Healthcare US, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211861
Marketing start: Apr 2, 2020
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 43547-457_b11d796e-584c-49a4-9f05-b499f5cd0f5eSPL ID b11d796e-584c-49a4-9f05-b499f5cd0f5eSPL set ID 89c5b52f-3c2a-41d5-8624-9ee51c512c72RxCUI 884655, 1600695UNII 6DPV8NK46S
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

N443547045710 followed by a unit qualifier and the quantity

Package 43547-0457-10. 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 15, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Amphetamine sulfate tablets, USP, are indicated for: 1. Narcolepsy 2. Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning d…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211861

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

FDA NDC Directory listings under ANDA 211861
Product	Strength	Form · route	Labeler	Product NDC
Amphetamine Sulfate	Amphetamine sulfate 10 mg/1	TabletOral	Solco Healthcare US, LLC	43547-458
Amphetamine Sulfate	Amphetamine sulfate 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-1368
Amphetamine Sulfate	Amphetamine sulfate 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-1369
Amphetamine Sulfate	Amphetamine sulfate 5 mg/1	TabletOral	Bryant Ranch Prepack	63629-1115
Amphetamine Sulfate	Amphetamine sulfate 10 mg/1	TabletOral	Bryant Ranch Prepack	63629-1114