olanzapine

Product NDC
70771-1418
11-digit product format
707711418
Labeler code
70771
Product ID
70771-1418_2b81ce33-92ca-45ed-ac5c-ab06a1dd8b00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA090459
Marketing category
ANDA
Marketing start
2019-01-03
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
8 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70771-1418DDiscontinued by firm2026-10-12
excluded packagepackage70771-141870771-1418-0DDiscontinued by firm2026-10-12
excluded packagepackage70771-141870771-1418-1DDiscontinued by firm2026-10-12
excluded packagepackage70771-141870771-1418-3DDiscontinued by firm2026-10-12
excluded packagepackage70771-141870771-1418-4DDiscontinued by firm2026-10-12
excluded packagepackage70771-141870771-1418-6DDiscontinued by firm2026-10-12

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-1418-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-1418-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-1418-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-1418-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-1418-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1418-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1418-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1418-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1418-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1418-1f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090459-001OLANZAPINEOLANZAPINE2.5MGTABLET / ORALAB2018-07-16
A090459-002OLANZAPINEOLANZAPINE5MGTABLET / ORALAB2018-07-16
A090459-003OLANZAPINEOLANZAPINE7.5MGTABLET / ORALAB2018-07-16
A090459-004OLANZAPINEOLANZAPINE10MGTABLET / ORALAB2018-07-16
A090459-005OLANZAPINEOLANZAPINE15MGTABLET / ORALAB2018-07-16
A090459-006OLANZAPINEOLANZAPINE20MGTABLET / ORALAB2018-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090459-001AB
A090459-002AB
A090459-003AB
A090459-004AB
A090459-005AB
A090459-006AB

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-08-18 06:07:402026-07A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-16b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090459-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090459-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090459-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A090459-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A090459-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A090459-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A090459-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090459-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090459-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-004AB1b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1418-0707711418001000 TABLET, FILM COATED in 1 BOTTLE (70771-1418-0) 2019-01-030000-00-00NoNoCurrent
70771-1418-170771141801100 TABLET, FILM COATED in 1 BOTTLE (70771-1418-1) 2019-01-030000-00-00NoNoCurrent
70771-1418-37077114180330 TABLET, FILM COATED in 1 BOTTLE (70771-1418-3) 2019-01-030000-00-00NoNoCurrent
70771-1418-47077114180410 BLISTER PACK in 1 CARTON (70771-1418-4) > 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1418-2) 10 blister pack2019-01-030000-00-00NoNoCurrent
70771-1418-67077114180660 TABLET, FILM COATED in 1 BOTTLE (70771-1418-6) 2019-01-030000-00-00NoNoCurrent