Home NDC 71335-1936 Olanzapine
Product NDC 71335-1936
11-digit product format 713351936
Labeler code 71335
Product ID 71335-1936_b5f709ac-f7d9-4da6-b633-c7e76daa62b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA202050
Marketing category ANDA
Marketing start 2012-04-23
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 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 A202050-001 OLANZAPINE OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 A202050-002 OLANZAPINE OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 A202050-003 OLANZAPINE OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 A202050-004 OLANZAPINE OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 A202050-005 OLANZAPINE OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 A202050-006 OLANZAPINE OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23
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 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 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
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 71335-1936-1 Olanzapine 30 in 1 BOTTLE TABLET 30 103 71335-1936-2 Olanzapine 60 in 1 BOTTLE TABLET 60 103 71335-1936-3 Olanzapine 90 in 1 BOTTLE TABLET 90 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1936 OLANZAPINE TABLET [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 3 package rows 20240726_4e90e30c-78a1-486f-a13c-f1ff798216be.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 Units Marketing start Marketing end Sample Exclude flag Status 71335-1936-1 71335193601 30 TABLET in 1 BOTTLE (71335-1936-1) 30 tablet 2024-07-18 0000-00-00 No No Current 71335-1936-2 71335193602 60 TABLET in 1 BOTTLE (71335-1936-2) 60 tablet 2024-07-18 0000-00-00 No No Current 71335-1936-3 71335193603 90 TABLET in 1 BOTTLE (71335-1936-3) 90 tablet 2024-07-18 0000-00-00 No No Current