Home NDC 70518-1465 Zyprexa
Product NDC 70518-1465
11-digit product format 705181465
Labeler code 70518
Product ID 70518-1465_92e4ed33-dbdb-c693-e053-2a95a90afb87
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA020592
Marketing category NDA
Marketing start 2018-10-04
Marketing end 0000-00-00
Substance OLANZAPINE
Active strength 5 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 24 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 70518-1465-0 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 70518-1465-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-1465-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-1465-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-1465-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-1465-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-1465-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-1465-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-1465-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-1465-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-1465-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-1465-0 557ba5c1ecfa…9c80585c8c6e…
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 N020592-001 ZYPREXA OLANZAPINE 2.5MG TABLET / ORAL AB RLD 1996-09-30 N020592-002 ZYPREXA OLANZAPINE 5MG TABLET / ORAL AB RLD, RS 1996-09-30 N020592-003 ZYPREXA OLANZAPINE 7.5MG TABLET / ORAL AB RLD 1996-09-30 N020592-004 ZYPREXA OLANZAPINE 10MG TABLET / ORAL AB RLD 1996-09-30 N020592-005 ZYPREXA OLANZAPINE 15MG TABLET / ORAL AB RLD 1997-09-09 N020592-006 ZYPREXA OLANZAPINE 20MG TABLET / ORAL AB RLD 1997-09-09
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 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zyprexa OLANZAPINE H2-Pharma LLC b418946a-1ab4-4d89-a012-d94fc361a3c4 2026-02-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020592 application number: NDA020592