Home NDC 0781-3159 Olanzapine
Product NDC 0781-3159
11-digit product format 007813159
Labeler code 0781
Product ID 0781-3159_e958c285-a1f2-4f4f-a864-50133543f41c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Sandoz Inc
Application ANDA201588
Marketing category ANDA
Marketing start 2011-10-24
Substance OLANZAPINE
Active strength 10 mg/2mL
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201588-001 OLANZAPINE OLANZAPINE 10MG/VIAL POWDER / INTRAMUSCULAR AP 2011-10-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201588-001 AP
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 2 · 41 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 A201588-001 OLANZAPINE 10MG/VIAL POWDER / INTRAMUSCULAR AP 2011-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201588-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2011-10-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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/2mL
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 485968 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 0781-3159-72 Olanzapine 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 12 0781-3159-72 Olanzapine 2 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 2 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OLANZAPINE ACTIVE INGREDIENT N7U69T4SZR OLANZAPINE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 4 OLANZAPINE ACTIVE MOIETY N7U69T4SZR OLANZAPINE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 4 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB OLANZAPINE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OLANZAPINE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I OLANZAPINE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 4 TARTARIC ACID INACTIVE INGREDIENT W4888I119H OLANZAPINE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 4 OLANZAPINE ACTIVE INGREDIENT N7U69T4SZR OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] 2 OLANZAPINE ACTIVE MOIETY N7U69T4SZR OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] 2 TARTARIC ACID INACTIVE INGREDIENT W4888I119H OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3159 OLANZAPINE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 11 Current NDC, Legacy NDC, 2 package rows 20250321_1e9666ef-4271-4834-8496-ccb3125d83db.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 0781-3159-72 00781315972 1 VIAL in 1 CARTON (0781-3159-72) / 2 mL in 1 VIAL 1 vial 2011-10-24 0000-00-00 No No Current