Home NDC 69543-383-90 Olanzapine
Product NDC 69543-383
Requested package NDC 69543-383-90
11-digit product format 695430383
Labeler code 69543
Product ID 69543-383_e78e66e4-82ab-47a9-8633-d304cb6bac1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET
Route ORAL
Labeler Virtus Pharmaceuticals, LLC
Application ANDA204319
Marketing category ANDA
Marketing start 2018-01-19
Marketing end 0000-00-00
Substance OLANZAPINE
Active strength 10 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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# 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 69543-383-90 69543038390 90 TABLET in 1 BOTTLE (69543-383-90) 90 tablet 2018-01-19 0000-00-00 No No Current