Home NDC 31722-308 Olanzapine
Product NDC 31722-308
11-digit product format 317220308
Labeler code 31722
Product ID 31722-308_19bd03f5-742b-ba6b-e063-6294a90a0551
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Camber Pharmaceuticals, Inc.
Application ANDA217466
Marketing category ANDA
Marketing start 2023-03-22
Substance OLANZAPINE
Active strength 10 mg/2mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217466-001 OLANZAPINE OLANZAPINE 10MG/VIAL POWDER / INTRAMUSCULAR AP 2023-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217466-001 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 A217466-001 OLANZAPINE 10MG/VIAL POWDER / INTRAMUSCULAR AP 2023-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A217466-001 OLANZAPINE 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP 2023-03-22 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217466-001 OLANZAPINE 10MG/VIAL POWDER / INTRAMUSCULAR AP 2023-03-22 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/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 31722-308-01 Olanzapine 2 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 2 2 31722-308-01 Olanzapine 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-308 OLANZAPINE (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.] 2 Current NDC, 2 package rows 20240601_c1387008-6dc4-4f1e-ae29-fa7a0f0be684.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 Sample Exclude flag Status 31722-308-01 31722030801 1 VIAL in 1 CARTON (31722-308-01) / 2 mL in 1 VIAL 1 vial 2023-03-22 No No Current