Home NDC 67877-173-85 Olanzapine
Product NDC 67877-173
Requested package NDC 67877-173-85
11-digit product format 678770173
Labeler code 67877
Product ID 67877-173_b4d4d6f0-2b78-4882-add2-7c6218270b7f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA202295
Marketing category ANDA
Marketing start 2012-01-01
Substance OLANZAPINE
Active strength 5 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A202295-001 OLANZAPINE OLANZAPINE 2.5MG TABLET / ORAL AB 2015-10-20 A202295-002 OLANZAPINE OLANZAPINE 5MG TABLET / ORAL AB 2015-10-20 A202295-003 OLANZAPINE OLANZAPINE 7.5MG TABLET / ORAL AB 2015-10-20 A202295-004 OLANZAPINE OLANZAPINE 10MG TABLET / ORAL AB 2015-10-20 A202295-005 OLANZAPINE OLANZAPINE 15MG TABLET / ORAL AB 2015-10-20 A202295-006 OLANZAPINE OLANZAPINE 20MG TABLET / ORAL AB 2015-10-20
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 · 252 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 2026-08-18 06:07:40 2026-07 A202295-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2015-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202295-002 OLANZAPINE 5MG TABLET / ORAL AB 2015-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202295-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2015-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202295-004 OLANZAPINE 10MG TABLET / ORAL AB 2015-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202295-005 OLANZAPINE 15MG TABLET / ORAL AB 2015-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202295-006 OLANZAPINE 20MG TABLET / ORAL AB 2015-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202295-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2015-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202295-002 OLANZAPINE 5MG TABLET / ORAL AB 2015-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202295-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2015-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202295-004 OLANZAPINE 10MG TABLET / ORAL AB 2015-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202295-005 OLANZAPINE 15MG TABLET / ORAL AB 2015-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202295-006 OLANZAPINE 20MG TABLET / ORAL AB 2015-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202295-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2015-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202295-002 OLANZAPINE 5MG TABLET / ORAL AB 2015-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202295-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2015-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202295-004 OLANZAPINE 10MG TABLET / ORAL AB 2015-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202295-005 OLANZAPINE 15MG TABLET / ORAL AB 2015-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202295-006 OLANZAPINE 20MG TABLET / ORAL AB 2015-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202295-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2015-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202295-002 OLANZAPINE 5MG TABLET / ORAL AB 2015-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202295-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2015-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202295-004 OLANZAPINE 10MG TABLET / ORAL AB 2015-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202295-005 OLANZAPINE 15MG TABLET / ORAL AB 2015-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202295-006 OLANZAPINE 20MG TABLET / ORAL AB 2015-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202295-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2015-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202295-002 OLANZAPINE 5MG TABLET / ORAL AB 2015-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202295-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2015-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202295-004 OLANZAPINE 10MG TABLET / ORAL AB 2015-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202295-005 OLANZAPINE 15MG TABLET / ORAL AB 2015-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202295-006 OLANZAPINE 20MG TABLET / ORAL AB 2015-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202295-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2015-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202295-002 OLANZAPINE 5MG TABLET / ORAL AB 2015-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202295-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2015-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202295-004 OLANZAPINE 10MG TABLET / ORAL AB 2015-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202295-005 OLANZAPINE 15MG TABLET / ORAL AB 2015-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202295-006 OLANZAPINE 20MG TABLET / ORAL AB 2015-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202295-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2015-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202295-002 OLANZAPINE 5MG TABLET / ORAL AB 2015-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202295-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2015-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202295-004 OLANZAPINE 10MG TABLET / ORAL AB 2015-10-20 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 252 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Olanzapine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLANZAPINE 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 67877-173-01 2022-10-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 67877-173-10 2022-10-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 67877-173-30 2022-10-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 67877-173-32 2022-10-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 67877-173-35 2022-10-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 67877-173-85 2022-10-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 67877-173-01 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 67877-173-10 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 67877-173-30 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 67877-173-32 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 67877-173-35 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 67877-173-85 2020-01-31 These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OLANZAPINE ACTIVE INGREDIENT N7U69T4SZR OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 OLANZAPINE ACTIVE MOIETY N7U69T4SZR OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 AMMONIA INACTIVE INGREDIENT 5138Q19F1X OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 MANNITOL INACTIVE INGREDIENT 3OWL53L36A OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 PECTIN INACTIVE INGREDIENT 89NA02M4RX OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 SHELLAC INACTIVE INGREDIENT 46N107B71O OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-173 OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] 9 Current NDC, Legacy NDC, 7 package rows 20221101_e8626e68-088d-47ff-bf06-489a778815aa.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 Units Marketing start Marketing end Sample Exclude flag Status 67877-173-85 67877017385 3 BLISTER PACK in 1 CARTON (67877-173-85) / 10 TABLET in 1 BLISTER PACK (67877-173-33) 3 blister pack 2012-01-01 0000-00-00 No No Current