Home NDC 13668-168-30 OLANZAPINE
Product NDC 13668-168
Requested package NDC 13668-168-30
11-digit product format 136680168
Labeler code 13668
Product ID 13668-168_1a64829a-2434-4c8d-8e58-9b28758e4b88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OLANZAPINE
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA091434
Marketing category ANDA
Marketing start 2026-02-28
Substance OLANZAPINE
Active strength 7.5 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A091434-001 OLANZAPINE OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 A091434-002 OLANZAPINE OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 A091434-003 OLANZAPINE OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 A091434-004 OLANZAPINE OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 A091434-005 OLANZAPINE OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 A091434-006 OLANZAPINE OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23
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 A091434-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091434-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091434-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091434-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091434-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091434-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091434-001 OLANZAPINE 2.5MG TABLET / ORAL 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091434-002 OLANZAPINE 5MG TABLET / ORAL 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091434-003 OLANZAPINE 7.5MG TABLET / ORAL 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091434-004 OLANZAPINE 10MG TABLET / ORAL 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091434-005 OLANZAPINE 15MG TABLET / ORAL 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091434-006 OLANZAPINE 20MG TABLET / ORAL 2012-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091434-001 OLANZAPINE 2.5MG TABLET / ORAL 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091434-002 OLANZAPINE 5MG TABLET / ORAL 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091434-003 OLANZAPINE 7.5MG TABLET / ORAL 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091434-004 OLANZAPINE 10MG TABLET / ORAL 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091434-005 OLANZAPINE 15MG TABLET / ORAL 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091434-006 OLANZAPINE 20MG TABLET / ORAL 2012-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091434-001 OLANZAPINE 2.5MG TABLET / ORAL 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091434-002 OLANZAPINE 5MG TABLET / ORAL 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091434-003 OLANZAPINE 7.5MG TABLET / ORAL 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091434-004 OLANZAPINE 10MG TABLET / ORAL 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091434-005 OLANZAPINE 15MG TABLET / ORAL 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091434-006 OLANZAPINE 20MG TABLET / ORAL 2012-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091434-001 OLANZAPINE 2.5MG TABLET / ORAL 2012-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091434-002 OLANZAPINE 5MG TABLET / ORAL 2012-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091434-003 OLANZAPINE 7.5MG TABLET / ORAL 2012-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091434-004 OLANZAPINE 10MG TABLET / ORAL 2012-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091434-005 OLANZAPINE 15MG TABLET / ORAL 2012-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091434-006 OLANZAPINE 20MG TABLET / ORAL 2012-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091434-001 OLANZAPINE 2.5MG TABLET / ORAL 2012-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091434-002 OLANZAPINE 5MG TABLET / ORAL 2012-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091434-003 OLANZAPINE 7.5MG TABLET / ORAL 2012-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091434-004 OLANZAPINE 10MG TABLET / ORAL 2012-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091434-005 OLANZAPINE 15MG TABLET / ORAL 2012-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091434-006 OLANZAPINE 20MG TABLET / ORAL 2012-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091434-001 OLANZAPINE 2.5MG TABLET / ORAL 2012-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091434-002 OLANZAPINE 5MG TABLET / ORAL 2012-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091434-003 OLANZAPINE 7.5MG TABLET / ORAL 2012-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091434-004 OLANZAPINE 10MG TABLET / ORAL 2012-04-23 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base OLANZAPINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLANZAPINE 7.5 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 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200034 Internal RxNorm lookup 283639 Internal RxNorm lookup 312076 Internal RxNorm lookup 312077 Internal RxNorm lookup 312078 Internal RxNorm lookup 312079 Internal RxNorm lookup 314154 Internal RxNorm lookup 314155 Internal RxNorm lookup 351107 Internal RxNorm lookup 351108 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OLANZAPINE ACTIVE INGREDIENT N7U69T4SZR OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] 6 OLANZAPINE ACTIVE MOIETY N7U69T4SZR OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] 6 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] 6 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] 6 MANNITOL INACTIVE INGREDIENT 3OWL53L36A OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-168 OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] 17 Current NDC, Legacy NDC, 6 package rows 20250305_2cb1bebe-0ced-46d8-bf21-c28a9acc4a15.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 Sample Exclude flag Status 13668-168-30 13668016830 30 TABLET in 1 BOTTLE (13668-168-30) 30 tablet 2026-02-28 No No Current