What is NDC 0378-0636?

0378-0636 is the product NDC for Iloperidone, Iloperidone 12 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Iloperidone?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Iloperidone NDC 0378-0636 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0636Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0636Add 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
0378-0636-01	0037806360100378063601	100 TABLET in 1 BOTTLE (0378-0636-01)Marketed from Mar 20, 2017
0378-0636-88	0037806368800378063688	10 BLISTER PACK in 1 CARTON (0378-0636-88) / 10 TABLET in 1 BLISTER PACKMarketed from Mar 20, 2017
0378-0636-91	0037806369100378063691	60 TABLET in 1 BOTTLE (0378-0636-91)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 — 12 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207231
Marketing start: Mar 20, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 0378-0636_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

N400378063601 followed by a unit qualifier and the quantity

Package 00378-0636-01. 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 Mar 13, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Iloperidone tablets is indicated for: Treatment of schizophrenia in adults [see Clinical Studies ( 14.1 )]. Iloperidone tablets is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 , 14.1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-0636

What is NDC 0378-0636?: 0378-0636 is the product NDC for Iloperidone, Iloperidone 12 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Iloperidone.
What is the active ingredient?: Iloperidone.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Iloperidone?: 6 other product NDCs are listed under this name. See all Iloperidone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Iloperidone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Iloperidone	Iloperidone 1 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0630	00378-0630-0100378-0630-8800378-0630-91
Iloperidone	Iloperidone 2 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0631	00378-0631-0100378-0631-8800378-0631-91
Iloperidone	Iloperidone 4 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0632	00378-0632-0100378-0632-8800378-0632-91
Iloperidone	Iloperidone 6 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0633	00378-0633-0100378-0633-8800378-0633-91
Iloperidone	Iloperidone 8 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0634	00378-0634-0100378-0634-8800378-0634-91
Iloperidone	Iloperidone 10 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0635	00378-0635-0100378-0635-8800378-0635-91

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 1 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0630
Iloperidone	Iloperidone 2 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0631
Iloperidone	Iloperidone 4 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0632
Iloperidone	Iloperidone 6 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0633
Iloperidone	Iloperidone 8 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0634
Iloperidone	Iloperidone 10 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0635