Olanzapine

Product NDC: 67046-1604
Requested package NDC: 67046-1604-3
11-digit product format: 670461604
Labeler code: 67046
Product ID: 67046-1604_40189aed-2898-e791-e063-6394a90a44f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA210022
Marketing category: ANDA
Marketing start: 2025-10-01
Substance: OLANZAPINE
Active strength: 20 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210022-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2023-02-24
A210022-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2023-02-24
A210022-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2023-02-24
A210022-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2023-02-24
A210022-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2023-02-24
A210022-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2023-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210022-001	AB
A210022-002	AB
A210022-003	AB
A210022-004	AB
A210022-005	AB
A210022-006	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 4 · 138 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	A210022-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2023-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210022-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2023-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210022-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2023-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210022-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2023-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210022-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2023-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210022-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2023-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2023-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210022-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210022-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210022-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210022-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210022-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210022-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2023-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2023-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2023-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2023-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2023-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2023-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2023-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2023-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2023-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2023-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2023-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2023-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2023-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2023-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2023-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2023-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2023-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2023-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2023-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210022-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2023-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210022-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2023-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210022-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2023-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210022-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2023-02-24	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 138 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	A210022-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210022-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210022-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210022-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210022-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210022-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210022-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210022-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210022-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210022-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210022-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210022-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210022-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210022-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210022-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210022-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210022-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210022-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210022-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210022-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Olanzapine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLANZAPINE	20 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283639	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
40187874-447a-de20-e063-6394a90aafe7	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	Strength	SPL version
67046-1604-3	Olanzapine	30 in 1 BLISTER PACK	TABLET	30		1

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Modavar Pharmaceuticals LLC	f0943b4e-6bdc-48c1-8ecd-39cf732e16f5	2026-04-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210022 application number: ANDA210022
Olanzapine	OLANZAPINE	Coupler LLC	495efc49-7cdb-4b9e-e063-6394a90a547e	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210022 application number: ANDA210022
Olanzapine	OLANZAPINE	Coupler LLC	42d9ad47-52cc-ad11-e063-6394a90aedca	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210022 application number: ANDA210022
Olanzapine	OLANZAPINE	Coupler LLC	40187874-447a-de20-e063-6394a90aafe7	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210022 application number: ANDA210022 ndc (package): 67046-1604-3 ndc (product): 67046-1604 ndc11 (package): 67046160403
Olanzapine	OLANZAPINE	Coupler LLC	3ed78a7d-4014-d280-e063-6294a90a8ee9	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210022 application number: ANDA210022
Olanzapine	OLANZAPINE	Cadila Pharmaceuticals Limited	2ae07ad4-4e58-4740-9f02-035ec061fefc	2025-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210022 application number: ANDA210022

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
283639	OLANZapine 20 MG Oral Tablet	PSN	40187874-447a-de20-e063-6394a90aafe7	1
283639	olanzapine 20 MG Oral Tablet	SCD	40187874-447a-de20-e063-6394a90aafe7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1604-3	67046160403	30 TABLET in 1 BLISTER PACK (67046-1604-3)	30 tablet	2025-10-01	No	No	Current