Olanzapine and Fluoxetine

Product NDC
0781-2195
11-digit product format
007812195
Labeler code
0781
Product ID
0781-2195_f4bd3301-a8f5-4edd-a188-e6ad773d3e29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine and Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA078901
Marketing category
ANDA
Marketing start
2012-11-30
Marketing end
0000-00-00
Substance
OLANZAPINE; FLUOXETINE HYDROCHLORIDE
Active strength
3 mg/1; mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-2195DDiscontinued by firm2026-10-05
excluded packagepackage0781-21950781-2195-31DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-2195-31d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-2195-31f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-2195-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-2195-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-2195-31cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-2195-31cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-2195-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-2195-31ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-2195-310efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-2195-31ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-2195-31367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-2195-31557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078901-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-16
A078901-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-16
A078901-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-16
A078901-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-16
A078901-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078901-001AB
A078901-002AB
A078901-003AB
A078901-004AB
A078901-005AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078901-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-1684e616aacf4f…
2026-09-14 22:38:342026-08A078901-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-1684e616aacf4f…
2026-09-14 22:38:342026-08A078901-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-1684e616aacf4f…
2026-09-14 22:38:342026-08A078901-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-1684e616aacf4f…
2026-09-14 22:38:342026-08A078901-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-1684e616aacf4f…
2026-08-18 06:07:402026-07A078901-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07A078901-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07A078901-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07A078901-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07A078901-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078901-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078901-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078901-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078901-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078901-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078901-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078901-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078901-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078901-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078901-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078901-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078901-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078901-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078901-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078901-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078901-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078901-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078901-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078901-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078901-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078901-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078901-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078901-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078901-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078901-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078901-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078901-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078901-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078901-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078901-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-1603ed91905a0d…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078901-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078901-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078901-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078901-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A078901-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A078901-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078901-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078901-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078901-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078901-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078901-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078901-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078901-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078901-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078901-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078901-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078901-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078901-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078901-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078901-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078901-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078901-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078901-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078901-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078901-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078901-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078901-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078901-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078901-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078901-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078901-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078901-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078901-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078901-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078901-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078901-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078901-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078901-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078901-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078901-005AB103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2195-31EA - Each0781-21957a87674f-5714-42ee-8701-eddee9a8876612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJOLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
FLUOXETINEACTIVE MOIETY01K63SUP8DOLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHOLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYOLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
GELATININACTIVE INGREDIENT2G86QN327LOLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
SHELLACINACTIVE INGREDIENT46N107B71OOLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE AND FLUOXETINE CAPSULE [SANDOZ INC]12