Home NDC 0832-6079-03 Olanzapine
Product NDC 0832-6079
Requested package NDC 0832-6079-03
11-digit product format 008326079
Labeler code 0832
Product ID 0832-6079_8360dfb0-5f3a-4b86-8b46-fc89c12aad6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA204319
Marketing category ANDA
Marketing start 2016-01-27
Marketing end 2026-08-31
Substance OLANZAPINE
Active strength 5 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 258 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 2026-09-14 22:38:34 2026-08 A204319-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2016-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204319-002 OLANZAPINE 5MG TABLET / ORAL AB 2016-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204319-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2016-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204319-004 OLANZAPINE 10MG TABLET / ORAL AB 2016-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204319-005 OLANZAPINE 15MG TABLET / ORAL AB 2016-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204319-006 OLANZAPINE 20MG TABLET / ORAL AB 2016-01-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204319-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2016-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204319-002 OLANZAPINE 5MG TABLET / ORAL AB 2016-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204319-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2016-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204319-004 OLANZAPINE 10MG TABLET / ORAL AB 2016-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204319-005 OLANZAPINE 15MG TABLET / ORAL AB 2016-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204319-006 OLANZAPINE 20MG TABLET / ORAL AB 2016-01-27 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0832-6079-03 Olanzapine 30 in 1 BOTTLE TABLET 30 2 0832-6079-50 Olanzapine 500 in 1 BOTTLE TABLET 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-6079 OLANZAPINE TABLET [UPSHER-SMITH LABORATORIES, LLC] 1 Current NDC, 2 package rows 20240807_dbe23f33-9e7d-49a7-8528-fa290661a96f.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Olanzapine OLANZAPINE Qilu Pharmaceutical Co., Ltd. 6077f5c4-01d7-4c1d-97a0-cb859f98ce68 2024-06-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204319 application number: ANDA204319
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 0832-6079-03 00832607903 30 TABLET in 1 BOTTLE (0832-6079-03) 30 tablet 2024-08-15 2026-08-31 No No Historical