Home NDC 42291-653 Olanzapine and Fluoxetine
Product NDC 42291-653
11-digit product format 422910653
Labeler code 42291
Product ID 42291-653_4135db41-e022-f3a8-e063-6394a90a3681
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine and Fluoxetine
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA077528
Marketing category ANDA
Marketing start 2014-01-21
Substance OLANZAPINE; FLUOXETINE HYDROCHLORIDE
Active strength 6; 25 mg/1; mg/1
Pharmacologic classes Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 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.
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 5 of 5 · 172 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 2022-09-29 23:25 UTC 2022-09 A077528-001 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-06-19 e64feba35796…2022-09-29 23:25 UTC 2022-09 A077528-002 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-06-19 e64feba35796…2022-09-29 23:25 UTC 2022-09 A077528-003 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-06-19 e64feba35796…2022-09-29 23:25 UTC 2022-09 A077528-004 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-06-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077528-001 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-06-19 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077528-002 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-06-19 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077528-003 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-06-19 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077528-004 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-06-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A077528-001 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-06-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A077528-002 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-06-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A077528-003 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RS 2012-06-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A077528-004 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-06-19 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLANZAPINE 6 mg/1 FLUOXETINE HYDROCHLORIDE 25 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-653-30 Olanzapine and Fluoxetine 30 in 1 BOTTLE CAPSULE 30 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 42291-653 OLANZAPINE AND FLUOXETINE CAPSULE [AVKARE] 7 Current NDC, Legacy NDC, 1 package rows 20240111_f5f78ed2-4640-8528-c51c-d7bffa045d48.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-653-30 42291065330 30 CAPSULE in 1 BOTTLE (42291-653-30) 30 capsule 2014-01-21 0000-00-00 No No Current