Iloperidone NDC 0378-0632

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0632Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0632Add 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
0378-0632-01	00378063201	100 TABLET in 1 BOTTLE (0378-0632-01)Marketed from Mar 20, 2017
0378-0632-88	00378063288	10 BLISTER PACK in 1 CARTON (0378-0632-88) / 10 TABLET in 1 BLISTER PACKMarketed from Mar 20, 2017
0378-0632-91	00378063291	60 TABLET in 1 BOTTLE (0378-0632-91)Marketed from Mar 20, 2017

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Iloperidone
Generic name (nonproprietary): iloperidone
Active ingredients: Iloperidone — 4 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207231
Marketing start: Mar 20, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 0378-0632_30392c6b-2f42-6e82-e063-6394a90a0c88SPL ID 30392c6b-2f42-6e82-e063-6394a90a0c88SPL set ID eeb0fcfd-e4e8-4fb1-9635-901dc9446235RxCUI 848722, 848728, 848732, 848736, 848740, 848744, 848748UNII VPO7KJ050NUPC 0303780631915, 0303780633919, 0303780636910, 0303780634916, 0303780632912, 0303780635913, 0303780630918
Pharmacologic class: Atypical Antipsychotic

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

N400378063201 followed by a unit qualifier and the quantity

Package 00378-0632-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 207231

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

FDA NDC Directory listings under ANDA 207231
Product	Strength	Form · route	Labeler	Product NDC
Iloperidone	Iloperidone 10 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0635
Iloperidone	Iloperidone 12 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0636
Iloperidone	Iloperidone 1 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0630
Iloperidone	Iloperidone 2 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0631
Iloperidone	Iloperidone 6 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0633
Iloperidone	Iloperidone 8 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0634