Olanzapine

Product NDC: 65862-657
Requested package NDC: 65862-657-03
11-digit product format: 658620657
Labeler code: 65862
Product ID: 65862-657_b691262a-e798-4bc7-985c-a047495bfd99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA203708
Marketing category: ANDA
Marketing start: 2014-05-15
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 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
A203708-001	OLANZAPINE	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15
A203708-002	OLANZAPINE	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15
A203708-003	OLANZAPINE	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15
A203708-004	OLANZAPINE	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203708-001	AB
A203708-002	AB
A203708-003	AB
A203708-004	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	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`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	A203708-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203708-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203708-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203708-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 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
4d768cfe-3b20-4127-95b9-b4151b28afcc	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
12d02c27-e8da-47f1-b815-ccca982731ef	Product name	9	20170802
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65862-657-03	Olanzapine	03 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	03		16
65862-657-10	Olanzapine	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-657-03	EA - Each	65862-657	36ed731e-6279-4bcf-a77d-6b02fa8d06e6	1	2015-06-09
65862-657-10	EA - Each	65862-657	44e3bdad-04a5-4af4-a6a3-0fa45317aca7	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	3
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	3
PINEAPPLE	INACTIVE INGREDIENT	2A88ZO081O	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	3
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	3
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-657	OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	14	Current NDC, Legacy NDC, 2 package rows	20250312_4d768cfe-3b20-4127-95b9-b4151b28afcc.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	Aurobindo Pharma Limited	4d768cfe-3b20-4127-95b9-b4151b28afcc	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203708 application number: ANDA203708 ndc (package): 65862-657-03 ndc (product): 65862-657 ndc11 (package): 65862065703

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
65862-657-03	65862065703	3 BLISTER PACK in 1 CARTON (65862-657-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-657-10)	3 blister pack	2014-05-15	0000-00-00	No	No	Current