Home NDC 55150-308 OLANZAPINE
Product NDC 55150-308
11-digit product format 551500308
Labeler code 55150
Product ID 55150-308_3f2bc4a3-93fe-42c3-aa91-0d1b337b81a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OLANZAPINE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Eugia US LLC
Application ANDA210968
Marketing category ANDA
Marketing start 2020-10-22
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 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 A210968-001 OLANZAPINE OLANZAPINE 10MG/VIAL POWDER / INTRAMUSCULAR AP 2020-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210968-001 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.
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 A210968-001 OLANZAPINE 10MG/VIAL POWDER / INTRAMUSCULAR AP 2020-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210968-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2020-10-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210968-001 OLANZAPINE 10MG/VIAL POWDER / INTRAMUSCULAR AP 2020-10-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 55150-308-01 OLANZAPINE 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 6 55150-308-01 OLANZAPINE 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 6 55150-308-10 OLANZAPINE 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 6 55150-308-10 OLANZAPINE 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-308 OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] 4 Current NDC, Legacy NDC, 4 package rows 20250322_9c745e2e-89d3-44d4-906e-704705c33310.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.
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 55150-308-01 55150030801 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2020-10-22 0000-00-00 No No Current 55150-308-10 55150030810 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2020-10-22 0000-00-00 No No Current