Olanzapine

Product NDC: 33342-070
11-digit product format: 333420070
Labeler code: 33342
Product ID: 33342-070_2b861570-6b18-4b2b-89aa-29ebde7770f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA202862
Marketing category: ANDA
Marketing start: 2014-08-22
Substance: OLANZAPINE
Active strength: 10 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202862-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15
A202862-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15
A202862-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15
A202862-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15
A202862-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15
A202862-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202862-001	AB
A202862-002	AB
A202862-003	AB
A202862-004	AB
A202862-005	AB
A202862-006	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 7 · 252 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
2026-08-18 06:07:40	2026-07	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202862-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202862-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202862-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-004	AB	1	`03ed91905a0d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLANZAPINE	10 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200034	Internal RxNorm lookup
283639	Internal RxNorm lookup
312077	Internal RxNorm lookup
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
8e095987-bdea-42f2-9550-c7155cf07d30	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
33342-070-07	Olanzapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	13
33342-070-11	Olanzapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	13
33342-070-12	Olanzapine	10 in 1 CARTON	TABLET, FILM COATED	10	13
33342-070-12	Olanzapine	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	13
33342-070-15	Olanzapine	500 in 1 BOTTLE	TABLET, FILM COATED	500	13
33342-070-44	Olanzapine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-070-07	EA - Each	33342-070	87721b09-d762-4d1e-badf-1d45fb0f69a1	1	2015-01-05
33342-070-15	EA - Each	33342-070	d6acdd4b-2819-42a1-a651-fd7fed660810	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	4
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-070	OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	12	Current NDC, Legacy NDC, 6 package rows	20250312_8e095987-bdea-42f2-9550-c7155cf07d30.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	5bded04a-d848-4ac6-b7c3-ff9b9fef3d29	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	9eb6b0d1-b301-4847-88f5-f8613d550ecc	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	PD-Rx Pharmaceuticals, Inc.	b6f0b2e2-3cbd-4564-8b3e-f811589af275	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	8e5ef52d-315b-4055-9e52-403e6f896f24	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Redpharm Drug	54adae9e-6781-6a77-e063-6394a90ab5c8	2026-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Coupler LLC	549dc142-adcd-99ed-e063-6294a90a37fa	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Coupler LLC	52bdaaaf-ab54-99d1-e063-6394a90a521f	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Coupler LLC	518a9400-edb8-6403-e063-6294a90a065d	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	76a6ff21-7157-4213-8073-35837a3ac07e	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Macleods Pharmaceuticals Limited	8e095987-bdea-42f2-9550-c7155cf07d30	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862 ndc (product): 33342-070
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	88edb3fc-fcb6-4483-859d-f830b077aca2	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	f6fd7ceb-1457-4c3e-9d30-4f658f39d37d	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	c47f90fc-49fe-4f60-9da8-1365a1650dd9	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	dcf8fcbf-636c-41ad-8084-c65ac2f117cc	2025-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	8586e828-34e7-4eb4-a933-6c688927478f	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	NCS HealthCare of KY, LLC dba Vangard Labs	87b7fb23-c9b7-433f-bd17-cd3e91714c27	2025-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Direct_Rx	fcec190f-b865-c5d3-e053-6394a90a7e45	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Direct_Rx	22528ae1-e36f-48e1-e063-6294a90a3dd2	2024-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	NorthStar RxLLC	ea3259d5-36ee-4ac9-b849-9625626e2187	2024-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Proficient Rx LP	ce66d545-015b-41d5-80c3-964d78e36bfd	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862

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
314154	OLANZapine 10 MG Oral Tablet	PSN	c47f90fc-49fe-4f60-9da8-1365a1650dd9	102
314154	olanzapine 10 MG Oral Tablet	SCD	c47f90fc-49fe-4f60-9da8-1365a1650dd9	102
314154	OLANZapine 10 MG Oral Tablet	PSN	f6fd7ceb-1457-4c3e-9d30-4f658f39d37d	101
314154	olanzapine 10 MG Oral Tablet	SCD	f6fd7ceb-1457-4c3e-9d30-4f658f39d37d	101
314154	OLANZapine 10 MG Oral Tablet	PSN	88edb3fc-fcb6-4483-859d-f830b077aca2	14
314154	olanzapine 10 MG Oral Tablet	SCD	88edb3fc-fcb6-4483-859d-f830b077aca2	14
314154	OLANZapine 10 MG Oral Tablet	PSN	87b7fb23-c9b7-433f-bd17-cd3e91714c27	13
314154	OLANZapine 10 MG Oral Tablet	PSN	8e095987-bdea-42f2-9550-c7155cf07d30	13
312077	OLANZapine 15 MG Oral Tablet	PSN	87b7fb23-c9b7-433f-bd17-cd3e91714c27	13
312077	OLANZapine 15 MG Oral Tablet	PSN	8e095987-bdea-42f2-9550-c7155cf07d30	13
200034	OLANZapine 2.5 MG Oral Tablet	PSN	87b7fb23-c9b7-433f-bd17-cd3e91714c27	13
200034	OLANZapine 2.5 MG Oral Tablet	PSN	8e095987-bdea-42f2-9550-c7155cf07d30	13
283639	OLANZapine 20 MG Oral Tablet	PSN	8e095987-bdea-42f2-9550-c7155cf07d30	13
283639	OLANZapine 20 MG Oral Tablet	PSN	87b7fb23-c9b7-433f-bd17-cd3e91714c27	13
312078	OLANZapine 5 MG Oral Tablet	PSN	8e095987-bdea-42f2-9550-c7155cf07d30	13
312078	OLANZapine 5 MG Oral Tablet	PSN	87b7fb23-c9b7-433f-bd17-cd3e91714c27	13
312079	OLANZapine 7.5 MG Oral Tablet	PSN	8e095987-bdea-42f2-9550-c7155cf07d30	13
314154	olanzapine 10 MG Oral Tablet	SCD	87b7fb23-c9b7-433f-bd17-cd3e91714c27	13
314154	olanzapine 10 MG Oral Tablet	SCD	8e095987-bdea-42f2-9550-c7155cf07d30	13
312077	olanzapine 15 MG Oral Tablet	SCD	8e095987-bdea-42f2-9550-c7155cf07d30	13
312077	olanzapine 15 MG Oral Tablet	SCD	87b7fb23-c9b7-433f-bd17-cd3e91714c27	13
200034	olanzapine 2.5 MG Oral Tablet	SCD	87b7fb23-c9b7-433f-bd17-cd3e91714c27	13
200034	olanzapine 2.5 MG Oral Tablet	SCD	8e095987-bdea-42f2-9550-c7155cf07d30	13
283639	olanzapine 20 MG Oral Tablet	SCD	8e095987-bdea-42f2-9550-c7155cf07d30	13
283639	olanzapine 20 MG Oral Tablet	SCD	87b7fb23-c9b7-433f-bd17-cd3e91714c27	13
312078	olanzapine 5 MG Oral Tablet	SCD	87b7fb23-c9b7-433f-bd17-cd3e91714c27	13
312078	olanzapine 5 MG Oral Tablet	SCD	8e095987-bdea-42f2-9550-c7155cf07d30	13
312079	olanzapine 7.5 MG Oral Tablet	SCD	8e095987-bdea-42f2-9550-c7155cf07d30	13
314154	OLANZapine 10 MG Oral Tablet	PSN	1f4a2eaf-3a12-4ebe-b97f-0a7bfbc32572	4
314154	olanzapine 10 MG Oral Tablet	SCD	1f4a2eaf-3a12-4ebe-b97f-0a7bfbc32572	4
314154	OLANZapine 10 MG Oral Tablet	PSN	5abc92df-b32f-c421-e053-2a91aa0a109d	1
314154	OLANZapine 10 MG Oral Tablet	PSN	518a9400-edb8-6403-e063-6294a90a065d	1
314154	olanzapine 10 MG Oral Tablet	SCD	5abc92df-b32f-c421-e053-2a91aa0a109d	1
314154	olanzapine 10 MG Oral Tablet	SCD	518a9400-edb8-6403-e063-6294a90a065d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
33342-070-07	33342007007	30 TABLET, FILM COATED in 1 BOTTLE (33342-070-07)		2014-08-22	0000-00-00	No	No	Current
33342-070-11	33342007011	100 TABLET, FILM COATED in 1 BOTTLE (33342-070-11)		2014-08-22	0000-00-00	No	No	Current
33342-070-12	33342007012	10 BLISTER PACK in 1 CARTON (33342-070-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2014-08-22	0000-00-00	No	No	Current
33342-070-15	33342007015	500 TABLET, FILM COATED in 1 BOTTLE (33342-070-15)		2014-08-22	0000-00-00	No	No	Current
33342-070-44	33342007044	1000 TABLET, FILM COATED in 1 BOTTLE (33342-070-44)		2014-08-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olanzapine	Coupler LLC	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	1
Olanzapine	Macleods Pharmaceuticals Limited	2026-03-05	Human Prescription Drug Label	13
Olanzapine	REMEDYREPACK INC.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	14
Olanzapine	Bryant Ranch Prepack	2025-05-21	HUMAN PRESCRIPTION DRUG LABEL	101
Olanzapine	Bryant Ranch Prepack	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	102
Olanzapine	NCS HealthCare of KY, LLC dba Vangard Labs	2025-03-03	HUMAN PRESCRIPTION DRUG LABEL	13
Olanzapine	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	4
Olanzapine	Quality Care Products, LLC	2020-05-19	Human Prescription Drug Label	1
Olanzapine	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2017-10-04	HUMAN PRESCRIPTION DRUG LABEL	1