Olanzapine

Product NDC
70518-1764
11-digit product format
705181764
Labeler code
70518
Product ID
70518-1764_4974003a-4507-1afb-e063-6394a90ae2d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076255
Marketing category
ANDA
Marketing start
2019-01-02
Substance
OLANZAPINE
Active strength
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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-1764-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-1764-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-1764-00efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076255-001OLANZAPINEOLANZAPINE2.5MGTABLET / ORALAB2012-04-23
A076255-002OLANZAPINEOLANZAPINE5MGTABLET / ORALAB2012-04-23
A076255-003OLANZAPINEOLANZAPINE7.5MGTABLET / ORALAB2012-04-23
A076255-004OLANZAPINEOLANZAPINE10MGTABLET / ORALAB2012-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076255-001AB
A076255-002AB
A076255-003AB
A076255-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-23d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076255-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076255-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076255-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312078Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d69af75-7615-4ec2-b7ef-467b2558c5c8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1764-0Olanzapine30 in 1 BLISTER PACKTABLET, FILM COATED3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1764OLANZAPINE TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 1 package rows20250210_3d69af75-7615-4ec2-b7ef-467b2558c5c8.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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEREMEDYREPACK INC.2a7300d3-95e3-427e-bf37-55fa654cc90a2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEREMEDYREPACK INC.3d69af75-7615-4ec2-b7ef-467b2558c5c82026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
ndc (product): 70518-1764
OlanzapineOLANZAPINEREMEDYREPACK INC.b513823d-927c-4111-8766-e6c37f84b2212026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEREMEDYREPACK INC.68de2a51-69b2-4d99-be79-36a95a4bc4752026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEMajor Pharmaceuticals0ecbf540-572e-4ca4-b694-18ca1cd1c1942026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEUnit Dose Solutions, Inc.55669a10-93f3-cfd6-e063-6294a90aa0e62026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEUnit Dose Solutions, Inc.55668be2-62ac-3252-e063-6394a90a40f72026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINECoupler LLC53e6b4e9-de26-16c3-e063-6294a90a77642026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINECoupler LLC52b99337-afa8-a6f9-e063-6294a90a20382026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINECoupler LLC51b64b6d-4676-a637-e063-6394a90a450c2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEDr. Reddy's Laboratories Inc.d474d5a9-d338-511d-5823-567c0a1bbf4d2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINECardinal Health 107, LLC38a89689-efc2-4931-8f65-868dc0248d6a2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEREMEDYREPACK INC.dc56c264-d10e-4059-b0d5-2feff16b345d2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEAmerican Health Packaging75616c31-8fed-4014-a9f2-4a028eccd5862025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.cfc0f187-d3ff-4bbb-9129-0e94c6eda0ee2025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.d349d5b7-5658-46d6-9bba-e6f6361cebb92025-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEPD-Rx Pharmaceuticals, Inc.10043041-a632-4e57-bc08-37216dea85462025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEBryant Ranch Prepack3c9963b1-c498-48a0-a3a1-1eaa6a1028fc2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEBryant Ranch Prepack09e48e71-4dd2-4538-91d7-5b284f6647d82023-03-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEDr. Reddy's Laboratories Ltd.9a57a63e-f856-aafa-037a-c08f2fea64962022-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312078OLANZapine 5 MG Oral TabletPSN3d69af75-7615-4ec2-b7ef-467b2558c5c812
312078olanzapine 5 MG Oral TabletSCD3d69af75-7615-4ec2-b7ef-467b2558c5c812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1764-07051817640030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1764-0) 2019-01-020000-00-00NoNoCurrent