OLANZAPINE

Product NDC: 50268-615
Requested package NDC: 50268-615-13
11-digit product format: 502680615
Labeler code: 50268
Product ID: 50268-615_d5de9d7e-79e3-5f96-e053-2995a90a3079
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OLANZAPINE
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: AvPAK
Application: ANDA091415
Marketing category: ANDA
Marketing start: 2014-04-23
Marketing end: 0000-00-00
Substance: OLANZAPINE
Active strength: 5 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50268-615	50268-615-13	D	Discontinued by firm		2026-08-03

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091415-001	OLANZAPINE	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25
A091415-002	OLANZAPINE	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25
A091415-003	OLANZAPINE	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25
A091415-004	OLANZAPINE	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091415-001	AB
A091415-002	AB
A091415-003	AB
A091415-004	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091415-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091415-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091415-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091415-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091415-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091415-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091415-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091415-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091415-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091415-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091415-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091415-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091415-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091415-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091415-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091415-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091415-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091415-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091415-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091415-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091415-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091415-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091415-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091415-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091415-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091415-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091415-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091415-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091415-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091415-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091415-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091415-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091415-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091415-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091415-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091415-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091415-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091415-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091415-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091415-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091415-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091415-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091415-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091415-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091415-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091415-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091415-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091415-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091415-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091415-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091415-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091415-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091415-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091415-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091415-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091415-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091415-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091415-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091415-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091415-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091415-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091415-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091415-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091415-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091415-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091415-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091415-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091415-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091415-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091415-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091415-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091415-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091415-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091415-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091415-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091415-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091415-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091415-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091415-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091415-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-615-11	EA - Each	50268-615	c9e906da-1623-4e1a-8c39-e163b0a35e94	1	2015-05-05
50268-615-13	EA - Each	50268-615	076f28c1-a706-40ab-a389-63eaacb9857c	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]	4
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]	4
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-615	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AVPAK]	11	Legacy NDC	20250112_98697cfd-5521-f8a9-af17-555031690b08.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLANZAPINE	OLANZAPINE	Torrent Pharmaceuticals Limited	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091415 application number: ANDA091415

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N7U69T4SZR	OLANZAPINE	132539-06-1	OLANZAPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-615-13	50268061513	30 BLISTER PACK in 1 BOX (50268-615-13) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50268-615-11)	30 blister pack	2014-04-23	0000-00-00	No	No	Current