Home NDC 68788-7161 Olanzapine
Product NDC 68788-7161
11-digit product format 687887161
Labeler code 68788
Product ID 68788-7161_21f5c530-cee9-4752-aab5-4d100fa6f391
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA202862
Marketing category ANDA
Marketing start 2018-06-05
Substance OLANZAPINE
Active strength 5 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 68788-7161-6 excluded package package 68788-7161-3 excluded package package 68788-7161-9
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202862-001 OLANZAPINE OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 A202862-002 OLANZAPINE OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 A202862-003 OLANZAPINE OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 A202862-004 OLANZAPINE OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 A202862-005 OLANZAPINE OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 A202862-006 OLANZAPINE OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 1 of 7 · 264 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 2026-10-15 13:18:30 2026-09 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 264 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLANZAPINE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N7U69T4SZR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312078 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 68788-7161-3 2020-12-01 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 68788-7161-3 2020-12-01 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 68788-7161-6 2020-12-01 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 68788-7161-6 2020-12-01 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 68788-7161-9 2020-12-01 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 68788-7161-9 2020-12-01 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 68788-7161-3 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 68788-7161-3 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 68788-7161-6 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 68788-7161-6 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 68788-7161-9 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 68788-7161-9 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-7161-3 Olanzapine 30 in 1 BOTTLE TABLET, FILM COATED 30 7 68788-7161-6 Olanzapine 60 in 1 BOTTLE TABLET, FILM COATED 60 7 68788-7161-9 Olanzapine 90 in 1 BOTTLE TABLET, FILM COATED 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7161 OLANZAPINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] 6 Current NDC, Legacy NDC, 3 package rows 20240726_5bded04a-d848-4ac6-b7c3-ff9b9fef3d29.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 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68788-7161-3 68788716103 30 TABLET, FILM COATED in 1 BOTTLE (68788-7161-3) 2018-06-05 0000-00-00 No No Current 68788-7161-6 68788716106 60 TABLET, FILM COATED in 1 BOTTLE (68788-7161-6) 2018-06-05 0000-00-00 No No Current 68788-7161-9 68788716109 90 TABLET, FILM COATED in 1 BOTTLE (68788-7161-9) 2018-06-05 0000-00-00 No No Current