OLANZAPINE

Product NDC
13668-168
Requested package NDC
13668-168-01
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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091434-001OLANZAPINEOLANZAPINE2.5MGTABLET / ORALAB2012-04-23
A091434-002OLANZAPINEOLANZAPINE5MGTABLET / ORALAB2012-04-23
A091434-003OLANZAPINEOLANZAPINE7.5MGTABLET / ORALAB2012-04-23
A091434-004OLANZAPINEOLANZAPINE10MGTABLET / ORALAB2012-04-23
A091434-005OLANZAPINEOLANZAPINE15MGTABLET / ORALAB2012-04-23
A091434-006OLANZAPINEOLANZAPINE20MGTABLET / ORALAB2012-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A091434-001AB
A091434-002AB
A091434-003AB
A091434-004AB
A091434-005AB
A091434-006AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091434-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091434-002OLANZAPINE5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091434-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091434-004OLANZAPINE10MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091434-005OLANZAPINE15MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091434-006OLANZAPINE20MGTABLET / ORALAB2012-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091434-001OLANZAPINE2.5MGTABLET / ORAL2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091434-002OLANZAPINE5MGTABLET / ORAL2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091434-003OLANZAPINE7.5MGTABLET / ORAL2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091434-004OLANZAPINE10MGTABLET / ORAL2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091434-005OLANZAPINE15MGTABLET / ORAL2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091434-006OLANZAPINE20MGTABLET / ORAL2012-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A091434-001OLANZAPINE2.5MGTABLET / ORAL2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091434-002OLANZAPINE5MGTABLET / ORAL2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091434-003OLANZAPINE7.5MGTABLET / ORAL2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091434-004OLANZAPINE10MGTABLET / ORAL2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091434-005OLANZAPINE15MGTABLET / ORAL2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091434-006OLANZAPINE20MGTABLET / ORAL2012-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091434-001OLANZAPINE2.5MGTABLET / ORAL2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091434-002OLANZAPINE5MGTABLET / ORAL2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091434-003OLANZAPINE7.5MGTABLET / ORAL2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091434-004OLANZAPINE10MGTABLET / ORAL2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091434-005OLANZAPINE15MGTABLET / ORAL2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091434-006OLANZAPINE20MGTABLET / ORAL2012-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091434-001OLANZAPINE2.5MGTABLET / ORAL2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091434-002OLANZAPINE5MGTABLET / ORAL2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091434-003OLANZAPINE7.5MGTABLET / ORAL2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091434-004OLANZAPINE10MGTABLET / ORAL2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091434-005OLANZAPINE15MGTABLET / ORAL2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091434-006OLANZAPINE20MGTABLET / ORAL2012-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091434-001OLANZAPINE2.5MGTABLET / ORAL2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091434-002OLANZAPINE5MGTABLET / ORAL2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091434-003OLANZAPINE7.5MGTABLET / ORAL2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091434-004OLANZAPINE10MGTABLET / ORAL2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091434-005OLANZAPINE15MGTABLET / ORAL2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091434-006OLANZAPINE20MGTABLET / ORAL2012-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091434-001OLANZAPINE2.5MGTABLET / ORAL2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091434-002OLANZAPINE5MGTABLET / ORAL2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091434-003OLANZAPINE7.5MGTABLET / ORAL2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091434-004OLANZAPINE10MGTABLET / ORAL2012-04-232680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091434-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091434-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091434-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091434-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091434-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091434-006AB1011fe1cb6892…
2019-12-13 00:20 UTC2019-12A091434-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091434-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091434-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091434-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091434-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091434-006AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A091434-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091434-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091434-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091434-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091434-005AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091434-006AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091434-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091434-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091434-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091434-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091434-005AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091434-006AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091434-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091434-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091434-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091434-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091434-005AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091434-006AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091434-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091434-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091434-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091434-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091434-005AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091434-006AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091434-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091434-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091434-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091434-004AB1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
OLANZAPINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N7U69T4SZRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200034Internal RxNorm lookup
283639Internal RxNorm lookup
312076Internal RxNorm lookup
312077Internal RxNorm lookup
312078Internal RxNorm lookup
312079Internal RxNorm lookup
314154Internal RxNorm lookup
314155Internal RxNorm lookup
351107Internal RxNorm lookup
351108Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cb1bebe-0ced-46d8-bf21-c28a9acc4a15Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-168-01OLANZAPINE100 in 1 BOTTLETABLET10019
13668-168-05OLANZAPINE500 in 1 BOTTLETABLET50019
13668-168-10OLANZAPINE1000 in 1 BOTTLETABLET100019
13668-168-20OLANZAPINE2000 in 1 BOTTLETABLET200019
13668-168-30OLANZAPINE30 in 1 BOTTLETABLET3019
13668-168-60OLANZAPINE60 in 1 BOTTLETABLET6019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-168-01EA - Each13668-16863ebc7c2-6934-4376-81d3-a7915e64c69d12012-07-24
13668-168-10EA - Each13668-1684681733a-787a-4431-a844-e02c266468ce12012-07-24
13668-168-30EA - Each13668-1682c9a5de7-552e-495d-ad58-e95691760f0512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-168OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]17Current NDC, Legacy NDC, 6 package rows20250305_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLANZAPINEOLANZAPINETorrent Pharmaceuticals Limited2cb1bebe-0ced-46d8-bf21-c28a9acc4a152026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091434
application number: ANDA091434
ndc (package): 13668-168-01
ndc (product): 13668-168
ndc11 (package): 13668016801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314154OLANZapine 10 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351107OLANZapine 15 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312077OLANZapine 15 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
200034OLANZapine 2.5 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351108OLANZapine 20 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
283639OLANZapine 20 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314155OLANZapine 5 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312078OLANZapine 5 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312079OLANZapine 7.5 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312076olanzapine 10 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314154olanzapine 10 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351107olanzapine 15 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312077olanzapine 15 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
200034olanzapine 2.5 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351108olanzapine 20 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
283639olanzapine 20 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314155olanzapine 5 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312078olanzapine 5 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312079olanzapine 7.5 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-168-0113668016801100 TABLET in 1 BOTTLE (13668-168-01) 100 tablet2026-02-28NoNoCurrent