Home NDC 67184-0563 Olanzapine
Product NDC 67184-0563
11-digit product format 671840563
Labeler code 67184
Product ID 67184-0563_69558fe2-90b3-411a-89bb-2405d37d4998
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET
Route ORAL
Labeler Qilu Pharmaceutical Co., Ltd.
Application ANDA204319
Marketing category ANDA
Marketing start 2016-01-27
Substance OLANZAPINE
Active strength 7.5 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Olanzapine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLANZAPINE 7.5 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200034 Internal RxNorm lookup 283639 Internal RxNorm lookup 312077 Internal RxNorm lookup 312078 Internal RxNorm lookup 312079 Internal RxNorm lookup 314154 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67184-0563-1 Olanzapine 30 in 1 BOTTLE TABLET 30 5 67184-0563-2 Olanzapine 100 in 1 BOTTLE TABLET 100 5 67184-0563-4 Olanzapine 800 in 1 BOTTLE TABLET 800 5 67184-0563-6 Olanzapine 90 in 1 BOTTLE TABLET 90 5 67184-0563-7 Olanzapine 500 in 1 BOTTLE TABLET 500 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67184-0563 OLANZAPINE TABLET [QILU PHARMACEUTICAL CO., LTD.] 5 Current NDC, Legacy NDC, 5 package rows 20240827_6077f5c4-01d7-4c1d-97a0-cb859f98ce68.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 Status 67184-0563-1 67184056301 30 in 1 BOTTLE Historical 67184-0563-2 67184056302 100 in 1 BOTTLE Historical 67184-0563-4 67184056304 800 in 1 BOTTLE Historical 67184-0563-6 67184056306 90 in 1 BOTTLE Historical 67184-0563-7 67184056307 500 in 1 BOTTLE Historical