Home NDC 72789-341 Olanzapine
Product NDC 72789-341
11-digit product format 727890341
Labeler code 72789
Product ID 72789-341_570c631d-1f6a-0681-e063-6394a90a38f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA202862
Marketing category ANDA
Marketing start 2014-08-22
Substance OLANZAPINE
Active strength 20 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 A202862-001 OLANZAPINE OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 A202862-002 OLANZAPINE OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 A202862-003 OLANZAPINE OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 A202862-004 OLANZAPINE OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 A202862-005 OLANZAPINE OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 A202862-006 OLANZAPINE OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15
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 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 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 20 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 283639 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 72789-341-90 Olanzapine 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-341 OLANZAPINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 14 Current NDC, 1 package rows 20250406_b6f0b2e2-3cbd-4564-8b3e-f811589af275.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 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72789-341-90 72789034190 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-341-90) 2023-08-01 No No Current