Olanzapine

Product NDC: 64380-175
11-digit product format: 643800175
Labeler code: 64380
Product ID: 64380-175_4b3cec46-acb7-4072-b226-d5c7c06b33b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olanzapine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA078109
Marketing category: ANDA
Marketing start: 2022-04-11
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 43.

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
A078109-001	OLANZAPINE	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24
A078109-002	OLANZAPINE	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24
A078109-003	OLANZAPINE	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24
A078109-004	OLANZAPINE	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078109-001	AB
A078109-002	AB
A078109-003	AB
A078109-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078109-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078109-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078109-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078109-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-004	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

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

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312076	Internal RxNorm lookup
314155	Internal RxNorm lookup
351107	Internal RxNorm lookup
351108	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
979c3212-36e8-4287-aace-bef0875188d7	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
64380-175-01	Olanzapine	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10		5
64380-175-02	Olanzapine	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-175-01	EA - Each	64380-175	6dbbf6ff-ff61-43cf-9901-1e6062053e3b	1	2024-04-05
64380-175-02	EA - Each	64380-175	9ba76b4e-2476-40db-8886-549de4887c45	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-175	OLANZAPINE TABLET, ORALLY DISINTEGRATING [STRIDES PHARMA SCIENCE LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20250226_979c3212-36e8-4287-aace-bef0875188d7.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	Strides Pharma Science Limited	979c3212-36e8-4287-aace-bef0875188d7	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078109 application number: ANDA078109 ndc (product): 64380-175

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
312076	OLANZapine 10 MG Disintegrating Oral Tablet	PSN	979c3212-36e8-4287-aace-bef0875188d7	5
351107	OLANZapine 15 MG Disintegrating Oral Tablet	PSN	979c3212-36e8-4287-aace-bef0875188d7	5
351108	OLANZapine 20 MG Disintegrating Oral Tablet	PSN	979c3212-36e8-4287-aace-bef0875188d7	5
314155	OLANZapine 5 MG Disintegrating Oral Tablet	PSN	979c3212-36e8-4287-aace-bef0875188d7	5
312076	olanzapine 10 MG Disintegrating Oral Tablet	SCD	979c3212-36e8-4287-aace-bef0875188d7	5
351107	olanzapine 15 MG Disintegrating Oral Tablet	SCD	979c3212-36e8-4287-aace-bef0875188d7	5
351108	olanzapine 20 MG Disintegrating Oral Tablet	SCD	979c3212-36e8-4287-aace-bef0875188d7	5
314155	olanzapine 5 MG Disintegrating Oral Tablet	SCD	979c3212-36e8-4287-aace-bef0875188d7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64380-175-01	64380017501	10 in 1 BLISTER PACK						Historical
64380-175-02	64380017502	3 BLISTER PACK in 1 CARTON (64380-175-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (64380-175-01)	3 blister pack	2022-04-11	0000-00-00	No	No	Current