What is NDC 42291-656?

42291-656 is the product NDC for Olanzapine and Fluoxetine, Olanzapine 12 mg/1; Fluoxetine hydrochloride 50 mg/1 capsule, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Olanzapine, Fluoxetine hydrochloride.

AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Olanzapine and Fluoxetine?

14 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Olanzapine and Fluoxetine NDC 42291-656

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-656Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0656Add 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
42291-656-30	4229106563042291065630	30 CAPSULE in 1 BOTTLE (42291-656-30)Marketed from Jan 21, 2014

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): Olanzapine and Fluoxetine
Generic name (nonproprietary): olanzapine and fluoxetine
Active ingredients: Olanzapine — 12 mg/1Fluoxetine hydrochloride — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077528
Marketing start: Jan 21, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 42291-656_4135db41-e022-f3a8-e063-6394a90a3681SPL ID 4135db41-e022-f3a8-e063-6394a90a3681SPL set ID f5f78ed2-4640-8528-c51c-d7bffa045d48RxCUI 403969, 403970, 403971, 403972, 721787UNII I9W7N6B1KJ, N7U69T4SZRUPC 0342291656307, 0342291654303, 0342291655300, 0342291653306, 0342291652309
Pharmacologic class: Atypical Antipsychotic; Serotonin Reuptake Inhibitor

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

N442291065630 followed by a unit qualifier and the quantity

Package 42291-0656-30. 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 Oct 15, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Olanzapine and fluoxetine capsules are indicated for the treatment of: Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1) ]. Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2) ]. Olanzapine and fluoxetine capsules combine olanzapine, an atypical antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor, indicated for treatment of: Acute Depressive Episodes Associated with Bipolar I Disorder (1) Treatment Resistant Depression (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-656

What is NDC 42291-656?: 42291-656 is the product NDC for Olanzapine and Fluoxetine, Olanzapine 12 mg/1; Fluoxetine hydrochloride 50 mg/1 capsule, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Olanzapine and Fluoxetine.
What is the active ingredient?: Olanzapine, Fluoxetine hydrochloride.
Who is the labeler?: AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Olanzapine and Fluoxetine?: 14 other product NDCs are listed under this name. See all Olanzapine and Fluoxetine 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 Olanzapine and Fluoxetine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Olanzapine and Fluoxetine	Olanzapine 3 mg/1; Fluoxetine hydrochloride 25 mg/1	CapsuleOral	AvKARE	42291-652	42291-0652-30
Olanzapine and Fluoxetine	Olanzapine 6 mg/1; Fluoxetine hydrochloride 25 mg/1	CapsuleOral	AvKARE	42291-653	42291-0653-30
Olanzapine and Fluoxetine	Olanzapine 6 mg/1; Fluoxetine hydrochloride 50 mg/1	CapsuleOral	AvKARE	42291-654	42291-0654-30
Olanzapine and Fluoxetine	Olanzapine 12 mg/1; Fluoxetine hydrochloride 25 mg/1	CapsuleOral	AvKARE	42291-655	42291-0655-30
Olanzapine and Fluoxetine	Olanzapine 3 mg/1; Fluoxetine hydrochloride 25 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0093-5503	00093-5503-56
Olanzapine and Fluoxetineolanzapine and fuoxetine	Olanzapine 6 mg/1; Fluoxetine hydrochloride 25 mg/1	CapsuleOral	Par Health USA, LLC	49884-250	49884-0250-11
Olanzapine and Fluoxetineolanzapine and fuoxetine	Olanzapine 6 mg/1; Fluoxetine hydrochloride 50 mg/1	CapsuleOral	Par Health USA, LLC	49884-251	49884-0251-11
Olanzapine and Fluoxetineolanzapine and fuoxetine	Olanzapine 12 mg/1; Fluoxetine hydrochloride 25 mg/1	CapsuleOral	Par Health USA, LLC	49884-252	49884-0252-11
Olanzapine and Fluoxetineolanzapine and fuoxetine	Olanzapine 12 mg/1; Fluoxetine hydrochloride 50 mg/1	CapsuleOral	Par Health USA, LLC	49884-253	49884-0253-11
Olanzapine and Fluoxetineolanzapine and fuoxetine	Olanzapine 3 mg/1; Fluoxetine hydrochloride 25 mg/1	CapsuleOral	Par Health USA, LLC	49884-277	49884-0277-11

All 15 Olanzapine and Fluoxetine NDCs

Other NDCs under ANDA 077528

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

FDA NDC Directory listings under ANDA 077528
Product	Strength	Form · route	Labeler	Product NDC
Olanzapine and Fluoxetine	Olanzapine 6 mg/1; Fluoxetine hydrochloride 25 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0093-5504
Olanzapine and Fluoxetine	Olanzapine 6 mg/1; Fluoxetine hydrochloride 50 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0093-5505
Olanzapine and Fluoxetine	Olanzapine 12 mg/1; Fluoxetine hydrochloride 25 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0093-5506
Olanzapine and Fluoxetine	Olanzapine 12 mg/1; Fluoxetine hydrochloride 50 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0093-5507
Olanzapine and Fluoxetine	Olanzapine 6 mg/1; Fluoxetine hydrochloride 25 mg/1	CapsuleOral	AvKARE	42291-653
Olanzapine and Fluoxetine	Olanzapine 6 mg/1; Fluoxetine hydrochloride 50 mg/1	CapsuleOral	AvKARE	42291-654
Olanzapine and Fluoxetine	Olanzapine 12 mg/1; Fluoxetine hydrochloride 25 mg/1	CapsuleOral	AvKARE	42291-655