Home NDC 0093-5767 Olanzapine
Product NDC 0093-5767
11-digit product format 000935767
Labeler code 0093
Product ID 0093-5767_69827204-6016-4105-ba6e-4bbda9a82b78
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076000
Marketing category ANDA
Marketing start 2011-10-24
Marketing end 0000-00-00
Substance OLANZAPINE
Active strength 3 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076000-001 OLANZAPINE OLANZAPINE 2.5MG TABLET / ORAL 2011-10-24 A076000-002 OLANZAPINE OLANZAPINE 5MG TABLET / ORAL 2011-10-24 A076000-003 OLANZAPINE OLANZAPINE 7.5MG TABLET / ORAL 2011-10-24 A076000-004 OLANZAPINE OLANZAPINE 10MG TABLET / ORAL 2011-10-24 A076000-005 OLANZAPINE OLANZAPINE 15MG TABLET / ORAL 2011-10-24
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 6 · 215 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 2026-09-14 22:38:34 2026-08 A076000-001 OLANZAPINE 2.5MG TABLET / ORAL 2011-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076000-002 OLANZAPINE 5MG TABLET / ORAL 2011-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076000-003 OLANZAPINE 7.5MG TABLET / ORAL 2011-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076000-004 OLANZAPINE 10MG TABLET / ORAL 2011-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076000-005 OLANZAPINE 15MG TABLET / ORAL 2011-10-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076000-001 OLANZAPINE 2.5MG TABLET / ORAL 2011-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076000-002 OLANZAPINE 5MG TABLET / ORAL 2011-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076000-003 OLANZAPINE 7.5MG TABLET / ORAL 2011-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076000-004 OLANZAPINE 10MG TABLET / ORAL 2011-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076000-005 OLANZAPINE 15MG TABLET / ORAL 2011-10-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076000-001 OLANZAPINE 2.5MG TABLET / ORAL 2011-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076000-002 OLANZAPINE 5MG TABLET / ORAL 2011-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076000-003 OLANZAPINE 7.5MG TABLET / ORAL 2011-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076000-004 OLANZAPINE 10MG TABLET / ORAL 2011-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076000-005 OLANZAPINE 15MG TABLET / ORAL 2011-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076000-001 OLANZAPINE 2.5MG TABLET / ORAL 2011-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076000-002 OLANZAPINE 5MG TABLET / ORAL 2011-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076000-003 OLANZAPINE 7.5MG TABLET / ORAL 2011-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076000-004 OLANZAPINE 10MG TABLET / ORAL 2011-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076000-005 OLANZAPINE 15MG TABLET / ORAL 2011-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076000-001 OLANZAPINE 2.5MG TABLET / ORAL 2011-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076000-002 OLANZAPINE 5MG TABLET / ORAL 2011-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076000-003 OLANZAPINE 7.5MG TABLET / ORAL 2011-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076000-004 OLANZAPINE 10MG TABLET / ORAL 2011-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076000-005 OLANZAPINE 15MG TABLET / ORAL 2011-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076000-001 OLANZAPINE 2.5MG TABLET / ORAL 2011-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076000-002 OLANZAPINE 5MG TABLET / ORAL 2011-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076000-003 OLANZAPINE 7.5MG TABLET / ORAL 2011-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076000-004 OLANZAPINE 10MG TABLET / ORAL 2011-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076000-005 OLANZAPINE 15MG TABLET / ORAL 2011-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076000-001 OLANZAPINE 2.5MG TABLET / ORAL 2011-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076000-002 OLANZAPINE 5MG TABLET / ORAL 2011-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076000-003 OLANZAPINE 7.5MG TABLET / ORAL 2011-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076000-004 OLANZAPINE 10MG TABLET / ORAL 2011-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076000-005 OLANZAPINE 15MG TABLET / ORAL 2011-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076000-001 OLANZAPINE 2.5MG TABLET / ORAL 2011-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076000-002 OLANZAPINE 5MG TABLET / ORAL 2011-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076000-003 OLANZAPINE 7.5MG TABLET / ORAL 2011-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076000-004 OLANZAPINE 10MG TABLET / ORAL 2011-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076000-005 OLANZAPINE 15MG TABLET / ORAL 2011-10-24 03ed91905a0d…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OLANZAPINE ACTIVE INGREDIENT N7U69T4SZR OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 OLANZAPINE ACTIVE MOIETY N7U69T4SZR OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OLANZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 8 OLANZAPINE ACTIVE INGREDIENT N7U69T4SZR OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 OLANZAPINE ACTIVE MOIETY N7U69T4SZR OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 OLANZAPINE ACTIVE INGREDIENT N7U69T4SZR OLANZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 Olanzapine ACTIVE INGREDIENT N7U69T4SZR OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 OLANZAPINE ACTIVE MOIETY N7U69T4SZR OLANZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 olanzapine ACTIVE MOIETY N7U69T4SZR OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OLANZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ OLANZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OLANZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OLANZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OLANZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B OLANZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OLANZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed RxNorm Mappings#