NDC 47781-178

NDC codes

FDA NDC Directory

Product NDC (as listed)47781-178Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47781-0178Add 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
47781-178-01	47781017801	100 TABLET in 1 BOTTLE (47781-178-01)Marketed from Jul 28, 2017

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, Amphetamine Sulfate Tablets,CII
Generic name (nonproprietary): dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets, 15 mg,cll
Active ingredients: Amphetamine aspartate monohydrate — 3.75 mg/1Amphetamine sulfate — 3.75 mg/1Dextroamphetamine saccharate — 3.75 mg/1Dextroamphetamine sulfate — 3.75 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alvogen Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207388
Marketing start: Jul 28, 2017
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 47781-178_eb490273-9334-1ae5-dd32-658e7fb0b40eSPL ID eb490273-9334-1ae5-dd32-658e7fb0b40e
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

N447781017801 followed by a unit qualifier and the quantity

Package 47781-0178-01. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 207388

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

FDA NDC Directory listings under ANDA 207388
Product	Strength	Form · route	Labeler	Product NDC
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CIIdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets, 5 mg,cll	Amphetamine aspartate monohydrate 1.25 mg/1 + 3 more ingredients	TabletOral	Alvogen Inc.	47781-174
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CIIdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets, 10 mg,cll	Amphetamine aspartate monohydrate 2.5 mg/1 + 3 more ingredients	TabletOral	Alvogen Inc.	47781-176
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CIIdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets, 20 mg,cll	Amphetamine aspartate monohydrate 5 mg/1 + 3 more ingredients	TabletOral	Alvogen Inc.	47781-179
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CIIdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets, 30 mg,cll	Amphetamine aspartate monohydrate 7.5 mg/1 + 3 more ingredients	TabletOral	Alvogen Inc.	47781-180

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII NDC 47781-178