Olanzapine and Fluoxetine

Product NDC: 49884-251
11-digit product format: 498840251
Labeler code: 49884
Product ID: 49884-251_b06f7f64-c457-4ca9-ad33-61efa6aec9b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olanzapine and fuoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA077742
Marketing category: ANDA
Marketing start: 2012-11-26
Substance: OLANZAPINE; FLUOXETINE HYDROCHLORIDE
Active strength: 6; 50 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 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077742-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-02
A077742-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02
A077742-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02
A077742-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02
A077742-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A077742-001	AB
A077742-002	AB
A077742-003	AB
A077742-004	AB
A077742-005	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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077742-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077742-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077742-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077742-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077742-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077742-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077742-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077742-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077742-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077742-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077742-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077742-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077742-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077742-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077742-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077742-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077742-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077742-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077742-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077742-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077742-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077742-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077742-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077742-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077742-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077742-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077742-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077742-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077742-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077742-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077742-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077742-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077742-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077742-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077742-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077742-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077742-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077742-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077742-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077742-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-02	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077742-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077742-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077742-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077742-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077742-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077742-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077742-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077742-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077742-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077742-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077742-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077742-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077742-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077742-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077742-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077742-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077742-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077742-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077742-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077742-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077742-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077742-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077742-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077742-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077742-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077742-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077742-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077742-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077742-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077742-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077742-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077742-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077742-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077742-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077742-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077742-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077742-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077742-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077742-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077742-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	6 mg/1
FLUOXETINE HYDROCHLORIDE	50 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
2f6ceda3-3edc-4427-98a6-23e3c930c44d	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
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
49884-251-11	Olanzapine and Fluoxetine	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-251-11	EA - Each	49884-251	717fdf6c-b6fc-4b0e-b14f-8458eb137356	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-251	OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [ENDO USA, INC.]	15	Current NDC, Legacy NDC, 1 package rows	20241215_2f6ceda3-3edc-4427-98a6-23e3c930c44d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine and Fluoxetine	OLANZAPINE AND FUOXETINE	Par Health USA, LLC	2f6ceda3-3edc-4427-98a6-23e3c930c44d	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077742 application number: ANDA077742 ndc (product): 49884-251

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

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	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
403971	OLANZapine 12 MG / FLUoxetine HCl 50 MG Oral Capsule	PSN	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
721787	OLANZapine 3 MG / FLUoxetine HCl 25 MG Oral Capsule	PSN	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
403969	OLANZapine 6 MG / FLUoxetine HCl 25 MG Oral Capsule	PSN	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
403972	OLANZapine 6 MG / FLUoxetine HCl 50 MG Oral Capsule	PSN	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
403970	fluoxetine 25 MG / olanzapine 12 MG Oral Capsule	SCD	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
721787	fluoxetine 25 MG / olanzapine 3 MG Oral Capsule	SCD	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
403969	fluoxetine 25 MG / olanzapine 6 MG Oral Capsule	SCD	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
403971	fluoxetine 50 MG / olanzapine 12 MG Oral Capsule	SCD	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
403972	fluoxetine 50 MG / olanzapine 6 MG Oral Capsule	SCD	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
403970	fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 12 MG Oral Capsule	SY	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
721787	fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 3 MG Oral Capsule	SY	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
403969	fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 6 MG Oral Capsule	SY	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
403971	fluoxetine 50 MG (as fluoxetine hydrochloride) / olanzapine 12 MG Oral Capsule	SY	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22
403972	fluoxetine 50 MG (as fluoxetine hydrochloride) / olanzapine 6 MG Oral Capsule	SY	2f6ceda3-3edc-4427-98a6-23e3c930c44d	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-251-11	49884025111	30 CAPSULE in 1 BOTTLE, PLASTIC (49884-251-11)	30 capsule	2012-11-26	0000-00-00	No	No	Current