olanzapine

Product NDC
68382-367
11-digit product format
683820367
Labeler code
68382
Product ID
68382-367_07ce1a1f-b10a-4dfc-a96e-15d1d7db3678
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA090459
Marketing category
ANDA
Marketing start
2019-01-03
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
10 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 productproduct68382-367DDiscontinued by firm2026-10-12
excluded packagepackage68382-36768382-367-01DDiscontinued by firm2026-10-12
excluded packagepackage68382-36768382-367-06DDiscontinued by firm2026-10-12
excluded packagepackage68382-36768382-367-10DDiscontinued by firm2026-10-12
excluded packagepackage68382-36768382-367-14DDiscontinued by firm2026-10-12
excluded packagepackage68382-36768382-367-77DDiscontinued 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 packagepackage68382-367-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-367-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-367-77d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-367-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-367-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-367-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-367-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-367-77f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-367-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-367-06f5e01cc5f278…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 5 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-14 00:12 UTC2019-12A090459-005AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090459-006AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090459-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090459-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090459-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090459-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090459-005AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090459-006AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090459-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090459-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090459-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090459-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090459-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090459-006AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090459-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090459-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090459-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090459-004AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090459-005AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090459-006AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090459-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090459-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090459-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090459-004AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090459-005AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090459-006AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090459-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090459-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090459-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090459-004AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090459-005AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090459-006AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090459-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090459-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090459-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090459-004AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090459-005AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090459-006AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090459-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090459-002AB19b2671bbb829…

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
68382-367-0168382036701100 TABLET, FILM COATED in 1 BOTTLE (68382-367-01) 2019-01-030000-00-00NoNoCurrent
68382-367-066838203670630 TABLET, FILM COATED in 1 BOTTLE (68382-367-06) 2019-01-030000-00-00NoNoCurrent
68382-367-10683820367101000 TABLET, FILM COATED in 1 BOTTLE (68382-367-10) 2019-01-030000-00-00NoNoCurrent
68382-367-146838203671460 TABLET, FILM COATED in 1 BOTTLE (68382-367-14) 2019-01-030000-00-00NoNoCurrent
68382-367-776838203677710 BLISTER PACK in 1 CARTON (68382-367-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-367-30) 10 blister pack2019-01-030000-00-00NoNoCurrent