Olanzapine and Fluoxetine

Product NDC: 0093-5504
11-digit product format: 000935504
Labeler code: 0093
Product ID: 0093-5504_debcba63-033a-446f-a086-ccdf9d790662
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine and Fluoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA077528
Marketing category: ANDA
Marketing start: 2012-06-19
Substance: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Active strength: 25; 6 mg/1; mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077528-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19
A077528-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19
A077528-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	RS	2012-06-19
A077528-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A077528-001	AB
A077528-002	AB
A077528-003	AB
A077528-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077528-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077528-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077528-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	RS	2012-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077528-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077528-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077528-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077528-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	RS	2012-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077528-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077528-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077528-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077528-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	RS	2012-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077528-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077528-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077528-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077528-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077528-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077528-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077528-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077528-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077528-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077528-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077528-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077528-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077528-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077528-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077528-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077528-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077528-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077528-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077528-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077528-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077528-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077528-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077528-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077528-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077528-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077528-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077528-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077528-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB		2012-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077528-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB		2012-06-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077528-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077528-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077528-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077528-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077528-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077528-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077528-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077528-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077528-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077528-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077528-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077528-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077528-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077528-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077528-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077528-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077528-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077528-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077528-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077528-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077528-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077528-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077528-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077528-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077528-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077528-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077528-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077528-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077528-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077528-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077528-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077528-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077528-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077528-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077528-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077528-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077528-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077528-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077528-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077528-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Olanzapine and Fluoxetine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLANZAPINE	25 mg/1
FLUOXETINE HYDROCHLORIDE	6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N7U69T4SZR	Internal UNII lookup
I9W7N6B1KJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403969	Internal RxNorm lookup
403970	Internal RxNorm lookup
403971	Internal RxNorm lookup
403972	Internal RxNorm lookup
721787	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3c28cf18-01a3-468a-ab3e-8aa82f918251	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9	Product name	6	20250331
e5b459e3-ddce-4802-aab4-2c901d71ae85	Product name	5	20250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464	Product name	3	20240130
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
e7177a8f-11de-ee90-ca22-068e6ef54cf5	Product name	4	20230104
42e9462d-db65-453b-8069-8fb2df9182e8	Product name	1	20211216
12d02c27-e8da-47f1-b815-ccca982731ef	Product name	9	20170802
82da1192-6e97-fa73-2f85-6a50c10b4704	Product name	3	20161212
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-5504-56	Olanzapine and Fluoxetine	30 in 1 BOTTLE	CAPSULE	30		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-5504-56	EA - Each	0093-5504	8618b25d-4d94-460f-b9eb-944ba21a32ac	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]	7
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FLUOXETINE) CAPSULE [AVKARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-5504	OLANZAPINE AND FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]	26	Current NDC, Legacy NDC, 1 package rows	20250411_3c28cf18-01a3-468a-ab3e-8aa82f918251.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine and Fluoxetine	OLANZAPINE AND FLUOXETINE	Teva Pharmaceuticals USA, Inc.	3c28cf18-01a3-468a-ab3e-8aa82f918251	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077528 application number: ANDA077528 ndc (product): 0093-5504
Olanzapine and Fluoxetine	OLANZAPINE AND FLUOXETINE	AvKARE	f5f78ed2-4640-8528-c51c-d7bffa045d48	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077528 application number: ANDA077528

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE	56296-78-7	FLUOXETINE HYDROCHLORIDE
N7U69T4SZR	OLANZAPINE	132539-06-1	OLANZAPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403970	OLANZapine 12 MG / FLUoxetine HCl 25 MG Oral Capsule	PSN	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403971	OLANZapine 12 MG / FLUoxetine HCl 50 MG Oral Capsule	PSN	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
721787	OLANZapine 3 MG / FLUoxetine HCl 25 MG Oral Capsule	PSN	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403969	OLANZapine 6 MG / FLUoxetine HCl 25 MG Oral Capsule	PSN	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403972	OLANZapine 6 MG / FLUoxetine HCl 50 MG Oral Capsule	PSN	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403970	fluoxetine 25 MG / olanzapine 12 MG Oral Capsule	SCD	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
721787	fluoxetine 25 MG / olanzapine 3 MG Oral Capsule	SCD	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403969	fluoxetine 25 MG / olanzapine 6 MG Oral Capsule	SCD	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403971	fluoxetine 50 MG / olanzapine 12 MG Oral Capsule	SCD	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403972	fluoxetine 50 MG / olanzapine 6 MG Oral Capsule	SCD	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403970	fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 12 MG Oral Capsule	SY	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
721787	fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 3 MG Oral Capsule	SY	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403969	fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 6 MG Oral Capsule	SY	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403971	fluoxetine 50 MG (as fluoxetine hydrochloride) / olanzapine 12 MG Oral Capsule	SY	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403972	fluoxetine 50 MG (as fluoxetine hydrochloride) / olanzapine 6 MG Oral Capsule	SY	3c28cf18-01a3-468a-ab3e-8aa82f918251	28
403970	OLANZapine 12 MG / FLUoxetine HCl 25 MG Oral Capsule	PSN	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
403971	OLANZapine 12 MG / FLUoxetine HCl 50 MG Oral Capsule	PSN	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
721787	OLANZapine 3 MG / FLUoxetine HCl 25 MG Oral Capsule	PSN	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
403969	OLANZapine 6 MG / FLUoxetine HCl 25 MG Oral Capsule	PSN	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
403972	OLANZapine 6 MG / FLUoxetine HCl 50 MG Oral Capsule	PSN	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
403970	fluoxetine 25 MG / olanzapine 12 MG Oral Capsule	SCD	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
721787	fluoxetine 25 MG / olanzapine 3 MG Oral Capsule	SCD	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
403969	fluoxetine 25 MG / olanzapine 6 MG Oral Capsule	SCD	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
403971	fluoxetine 50 MG / olanzapine 12 MG Oral Capsule	SCD	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
403972	fluoxetine 50 MG / olanzapine 6 MG Oral Capsule	SCD	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
403970	fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 12 MG Oral Capsule	SY	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
721787	fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 3 MG Oral Capsule	SY	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
403969	fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 6 MG Oral Capsule	SY	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
403971	fluoxetine 50 MG (as fluoxetine hydrochloride) / olanzapine 12 MG Oral Capsule	SY	f5f78ed2-4640-8528-c51c-d7bffa045d48	8
403972	fluoxetine 50 MG (as fluoxetine hydrochloride) / olanzapine 6 MG Oral Capsule	SY	f5f78ed2-4640-8528-c51c-d7bffa045d48	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-5504-56	00093550456	30 CAPSULE in 1 BOTTLE (0093-5504-56)	30 capsule	2012-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olanzapine and Fluoxetine	Teva Pharmaceuticals USA, Inc.	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	28
Olanzapine and Fluoxetine	AvKARE	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	8