Home NDC 71335-1363 Olanzapine
Product NDC 71335-1363
11-digit product format 713351363
Labeler code 71335
Product ID 71335-1363_1aaf5998-877d-455f-9318-443415bc5168
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA204319
Marketing category ANDA
Marketing start 2018-01-19
Marketing end 0000-00-00
Substance OLANZAPINE
Active strength 5 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-1363-2 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-1363-3 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-1363-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-1363-2 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-1363-3 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-1363-1 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A204319-001 OLANZAPINE OLANZAPINE 2.5MG TABLET / ORAL AB 2016-01-27 A204319-002 OLANZAPINE OLANZAPINE 5MG TABLET / ORAL AB 2016-01-27 A204319-003 OLANZAPINE OLANZAPINE 7.5MG TABLET / ORAL AB 2016-01-27 A204319-004 OLANZAPINE OLANZAPINE 10MG TABLET / ORAL AB 2016-01-27 A204319-005 OLANZAPINE OLANZAPINE 15MG TABLET / ORAL AB 2016-01-27 A204319-006 OLANZAPINE OLANZAPINE 20MG TABLET / ORAL AB 2016-01-27
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 · 246 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 A204319-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2016-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204319-002 OLANZAPINE 5MG TABLET / ORAL AB 2016-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204319-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2016-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204319-004 OLANZAPINE 10MG TABLET / ORAL AB 2016-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204319-005 OLANZAPINE 15MG TABLET / ORAL AB 2016-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204319-006 OLANZAPINE 20MG TABLET / ORAL AB 2016-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204319-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2016-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204319-002 OLANZAPINE 5MG TABLET / ORAL AB 2016-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204319-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2016-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204319-004 OLANZAPINE 10MG TABLET / ORAL AB 2016-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204319-005 OLANZAPINE 15MG TABLET / ORAL AB 2016-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204319-006 OLANZAPINE 20MG TABLET / ORAL AB 2016-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204319-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2016-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204319-002 OLANZAPINE 5MG TABLET / ORAL AB 2016-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204319-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2016-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204319-004 OLANZAPINE 10MG TABLET / ORAL AB 2016-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204319-005 OLANZAPINE 15MG TABLET / ORAL AB 2016-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204319-006 OLANZAPINE 20MG TABLET / ORAL AB 2016-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204319-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2016-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204319-002 OLANZAPINE 5MG TABLET / ORAL AB 2016-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204319-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2016-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204319-004 OLANZAPINE 10MG TABLET / ORAL AB 2016-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204319-005 OLANZAPINE 15MG TABLET / ORAL AB 2016-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204319-006 OLANZAPINE 20MG TABLET / ORAL AB 2016-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204319-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2016-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204319-002 OLANZAPINE 5MG TABLET / ORAL AB 2016-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204319-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2016-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204319-004 OLANZAPINE 10MG TABLET / ORAL AB 2016-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204319-005 OLANZAPINE 15MG TABLET / ORAL AB 2016-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204319-006 OLANZAPINE 20MG TABLET / ORAL AB 2016-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204319-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2016-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204319-002 OLANZAPINE 5MG TABLET / ORAL AB 2016-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204319-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2016-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204319-004 OLANZAPINE 10MG TABLET / ORAL AB 2016-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204319-005 OLANZAPINE 15MG TABLET / ORAL AB 2016-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204319-006 OLANZAPINE 20MG TABLET / ORAL AB 2016-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204319-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2016-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204319-002 OLANZAPINE 5MG TABLET / ORAL AB 2016-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204319-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2016-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204319-004 OLANZAPINE 10MG TABLET / ORAL AB 2016-01-27 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1363-1 Olanzapine 30 in 1 BOTTLE TABLET 30 6 71335-1363-2 Olanzapine 15 in 1 BOTTLE TABLET 15 6 71335-1363-3 Olanzapine 60 in 1 BOTTLE TABLET 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1363 OLANZAPINE TABLET [BRYANT RANCH PREPACK] 6 Legacy NDC, 3 package rows 20231025_760a905c-548c-4d4f-ae4b-06624bf3f76f.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 71335-1363-1 71335136301 30 TABLET in 1 BOTTLE (71335-1363-1) 30 tablet 2019-10-10 0000-00-00 No No Current 71335-1363-2 71335136302 15 TABLET in 1 BOTTLE (71335-1363-2) 15 tablet 2019-10-10 0000-00-00 No No Current 71335-1363-3 71335136303 60 TABLET in 1 BOTTLE (71335-1363-3) 60 tablet 2019-10-10 0000-00-00 No No Current