Home NDC 72303-0835 OLANZAPINE
Product NDC 72303-0835
11-digit product format 723030835
Labeler code 72303
Product ID 72303-0835_4d2e9776-65f4-cb00-e063-6394a90a1bf7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET
Route ORAL
Labeler HEC Pharm USA Inc.
Application ANDA206238
Marketing category ANDA
Marketing start 2018-11-30
Substance OLANZAPINE
Active strength 2.5 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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206238-001 OLANZAPINE OLANZAPINE 2.5MG TABLET / ORAL AB 2018-11-19 A206238-002 OLANZAPINE OLANZAPINE 5MG TABLET / ORAL AB 2018-11-19 A206238-003 OLANZAPINE OLANZAPINE 7.5MG TABLET / ORAL AB 2018-11-19 A206238-004 OLANZAPINE OLANZAPINE 10MG TABLET / ORAL AB 2018-11-19 A206238-005 OLANZAPINE OLANZAPINE 15MG TABLET / ORAL AB 2018-11-19 A206238-006 OLANZAPINE OLANZAPINE 20MG TABLET / ORAL AB 2018-11-19
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 · 246 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 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 2680178bc6a6…
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 A206238-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206238-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206238-003 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206238-004 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206238-005 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206238-006 AB 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 2.5 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200034 Internal RxNorm lookup 283639 Internal RxNorm lookup 312077 Internal RxNorm lookup 312078 Internal RxNorm lookup 312079 Internal RxNorm lookup 314154 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 72303-0835-1 OLANZAPINE 30 in 1 BOTTLE, PLASTIC TABLET 30 1
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 Units Marketing start Sample Exclude flag Status 72303-0835-1 72303083501 30 TABLET in 1 BOTTLE, PLASTIC (72303-0835-1) 30 tablet 2018-11-30 No No Current