NDC codes

FDA NDC Directory
Product NDC (as listed)70010-041Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70010-0041Add 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
70010-041-0170010004101100 TABLET in 1 BOTTLE (70010-041-01)Marketed from Aug 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)
Amphetamine Sulfate
Generic name (nonproprietary)
amphetamine sulfate
Active ingredients
Amphetamine sulfate — 10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212619
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 70010-041_56a441c6-0e1f-e7ba-e063-6394a90a7cd6SPL ID 56a441c6-0e1f-e7ba-e063-6394a90a7cd6SPL set ID 26dbad66-13c4-4906-88b3-ab7ee191466cRxCUI 884655, 1600695UNII 6DPV8NK46SUPC 0370010040014, 0370010041011

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

N470010004101 followed by a unit qualifier and the quantity

Package 70010-0041-01. 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 Amphetamine sulfate tablets, USP are indicated for: Narcolepsy 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 disabili…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212619

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

FDA NDC Directory listings under ANDA 212619
ProductStrengthForm · routeLabelerProduct NDC
Amphetamine SulfateAmphetamine sulfate 5 mg/1TabletOralGranules Pharmaceuticals Inc.70010-040

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