Olanzapine

Product NDC: 43598-165
Requested package NDC: 43598-165-78
11-digit product format: 435980165
Labeler code: 43598
Product ID: 43598-165_9f9b5830-1420-24fc-73be-4a040ccb22db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc.
Application: ANDA076255
Marketing category: ANDA
Marketing start: 2013-12-10
Substance: OLANZAPINE
Active strength: 7.5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A076255-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23
A076255-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23
A076255-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23
A076255-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076255-001	AB
A076255-002	AB
A076255-003	AB
A076255-004	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	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`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	A076255-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076255-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076255-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLANZAPINE	7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N7U69T4SZR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312078	Internal RxNorm lookup
312079	Internal RxNorm lookup
314154	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d474d5a9-d338-511d-5823-567c0a1bbf4d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
42e9462d-db65-453b-8069-8fb2df9182e8	Product name	1	20211216
12d02c27-e8da-47f1-b815-ccca982731ef	Product name	9	20170802
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43598-165-01	Olanzapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	13
43598-165-05	Olanzapine	500 in 1 BOTTLE	TABLET, FILM COATED	500	13
43598-165-30	Olanzapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	13
43598-165-60	Olanzapine	60 in 1 BOTTLE	TABLET, FILM COATED	60	13
43598-165-78	Olanzapine	10 in 1 CARTON	TABLET, FILM COATED	10	13
43598-165-79	Olanzapine	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-165-05	EA - Each	43598-165	756bffe1-1d02-4f7e-bbeb-5f0b6c326e18	1	2014-02-04
43598-165-30	EA - Each	43598-165	36473e40-000d-4e7b-9a0f-42edb8107046	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
olanzapine	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	4
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	4
Crospovidone	INACTIVE INGREDIENT	68401960MK	OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	4
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	4
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	4
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-165	OLANZAPINE TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.]	13	Current NDC, Legacy NDC, 6 package rows	20250429_d474d5a9-d338-511d-5823-567c0a1bbf4d.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	2a7300d3-95e3-427e-bf37-55fa654cc90a	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	3d69af75-7615-4ec2-b7ef-467b2558c5c8	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	b513823d-927c-4111-8766-e6c37f84b221	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	68de2a51-69b2-4d99-be79-36a95a4bc475	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Major Pharmaceuticals	0ecbf540-572e-4ca4-b694-18ca1cd1c194	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Unit Dose Solutions, Inc.	55669a10-93f3-cfd6-e063-6294a90aa0e6	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Unit Dose Solutions, Inc.	55668be2-62ac-3252-e063-6394a90a40f7	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Coupler LLC	53e6b4e9-de26-16c3-e063-6294a90a7764	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Coupler LLC	52b99337-afa8-a6f9-e063-6294a90a2038	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Coupler LLC	51b64b6d-4676-a637-e063-6394a90a450c	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Inc.	d474d5a9-d338-511d-5823-567c0a1bbf4d	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255 ndc (package): 43598-165-78 ndc (product): 43598-165 ndc11 (package): 43598016578
Olanzapine	OLANZAPINE	Cardinal Health 107, LLC	38a89689-efc2-4931-8f65-868dc0248d6a	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	dc56c264-d10e-4059-b0d5-2feff16b345d	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	American Health Packaging	75616c31-8fed-4014-a9f2-4a028eccd586	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	cfc0f187-d3ff-4bbb-9129-0e94c6eda0ee	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	d349d5b7-5658-46d6-9bba-e6f6361cebb9	2025-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	PD-Rx Pharmaceuticals, Inc.	10043041-a632-4e57-bc08-37216dea8546	2025-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	3c9963b1-c498-48a0-a3a1-1eaa6a1028fc	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	09e48e71-4dd2-4538-91d7-5b284f6647d8	2023-03-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Ltd.	9a57a63e-f856-aafa-037a-c08f2fea6496	2022-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312079	OLANZapine 7.5 MG Oral Tablet	PSN	68de2a51-69b2-4d99-be79-36a95a4bc475	17
312079	olanzapine 7.5 MG Oral Tablet	SCD	68de2a51-69b2-4d99-be79-36a95a4bc475	17
314154	OLANZapine 10 MG Oral Tablet	PSN	d474d5a9-d338-511d-5823-567c0a1bbf4d	13
312078	OLANZapine 5 MG Oral Tablet	PSN	d474d5a9-d338-511d-5823-567c0a1bbf4d	13
312079	OLANZapine 7.5 MG Oral Tablet	PSN	d474d5a9-d338-511d-5823-567c0a1bbf4d	13
314154	olanzapine 10 MG Oral Tablet	SCD	d474d5a9-d338-511d-5823-567c0a1bbf4d	13
312078	olanzapine 5 MG Oral Tablet	SCD	d474d5a9-d338-511d-5823-567c0a1bbf4d	13
312079	olanzapine 7.5 MG Oral Tablet	SCD	d474d5a9-d338-511d-5823-567c0a1bbf4d	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-165-78	43598016578	10 BLISTER PACK in 1 CARTON (43598-165-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-165-79)	10 blister pack	2013-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olanzapine	REMEDYREPACK INC.	2026-07-08	HUMAN PRESCRIPTION DRUG LABEL	18
Olanzapine	Coupler LLC	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	1
Olanzapine	Dr. Reddy's Laboratories Inc. \| Dr.Reddy's Laboratories Limited-FTO3	2026-03-09	HUMAN PRESCRIPTION DRUG LABEL	14