Home NDC 70518-0921 Olanzapine
Product NDC 70518-0921
11-digit product format 705180921
Labeler code 70518
Product ID 70518-0921_5c2ac99e-9f44-2e5c-e063-6394a90afbe0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA202862
Marketing category ANDA
Marketing start 2017-12-26
Substance OLANZAPINE
Active strength 10 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-0921 70518-0921-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-0921 70518-0921-1 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 10 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-0921-0 Olanzapine 30 in 1 BLISTER PACK TABLET, FILM COATED 30 14 70518-0921-1 Olanzapine 30 in 1 BLISTER PACK TABLET, FILM COATED 30 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-0921 OLANZAPINE TABLET, FILM COATED [REMEDYREPACK INC.] 10 Current NDC, Legacy NDC, 2 package rows 20250504_88edb3fc-fcb6-4483-859d-f830b077aca2.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 70518-0921-0 70518092100 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0921-0) 2017-12-26 0000-00-00 No No Current 70518-0921-1 70518092101 30 in 1 BLISTER PACK Historical