Home NDC 83854-003 OLANZAPINE
Product NDC 83854-003
11-digit product format 838540003
Labeler code 83854
Product ID 83854-003_4c557545-1a58-5183-e063-6394a90a1028
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OLANZAPINE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Anthea Pharma Private Limited
Application ANDA220323
Marketing category ANDA
Marketing start 2026-03-05
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 A220323-001 OLANZAPINE OLANZAPINE 10MG/VIAL POWDER / INTRAMUSCULAR AP 2026-03-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220323-001 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220323-001 OLANZAPINE 10MG/VIAL POWDER / INTRAMUSCULAR AP 2026-03-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220323-001 AP 1 a50c72e98297…
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 83854-003-01 OLANZAPINE 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 83854-003-01 OLANZAPINE 2 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 2 4
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 83854-003-01 83854000301 1 VIAL in 1 CARTON (83854-003-01) / 2 mL in 1 VIAL 1 vial 2026-03-05 No No Current