Olanzapine

Product NDC: 0093-5248
11-digit product format: 000935248
Labeler code: 0093
Product ID: 0093-5248_379692bf-82b3-48f3-8d1f-5a27949ce441
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA077243
Marketing category: ANDA
Marketing start: 2012-01-24
Substance: OLANZAPINE
Active strength: 20 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 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
A077243-001	OLANZAPINE	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30
A077243-002	OLANZAPINE	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30
A077243-003	OLANZAPINE	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30
A077243-004	OLANZAPINE	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077243-001	AB
A077243-002	AB
A077243-003	AB
A077243-004	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	A077243-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077243-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077243-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077243-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077243-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077243-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077243-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077243-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077243-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077243-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077243-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077243-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077243-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077243-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077243-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077243-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077243-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077243-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077243-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077243-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077243-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077243-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077243-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077243-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077243-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077243-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077243-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077243-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077243-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077243-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077243-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077243-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077243-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077243-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077243-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077243-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077243-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077243-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077243-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077243-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-01-30	`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	A077243-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077243-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077243-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077243-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077243-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077243-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077243-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077243-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077243-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077243-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077243-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077243-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077243-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077243-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077243-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077243-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077243-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077243-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077243-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077243-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077243-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077243-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077243-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077243-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077243-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077243-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077243-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077243-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077243-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077243-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077243-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077243-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077243-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077243-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077243-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077243-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077243-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077243-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077243-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077243-004	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	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
dd0b2525-4e2f-44fc-9302-0ae4ebb1e135	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
0093-5248-19	Olanzapine	1 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	1		18
0093-5248-65	Olanzapine	30 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	30		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-5248-19	EA - Each	0093-5248	0f8f0a88-9499-4e16-a7b2-3f2e1aefccd5	1	2013-02-13
0093-5248-65	EA - Each	0093-5248	e8a132fb-1969-471d-89c4-5b2ca9b0a2bd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	6
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	6
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	6
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	6
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	6
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-5248	OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA, INC.]	16	Current NDC, Legacy NDC, 2 package rows	20250418_dd0b2525-4e2f-44fc-9302-0ae4ebb1e135.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	Teva Pharmaceuticals USA, Inc.	dd0b2525-4e2f-44fc-9302-0ae4ebb1e135	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077243 application number: ANDA077243 ndc (product): 0093-5248

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	dd0b2525-4e2f-44fc-9302-0ae4ebb1e135	18
351107	OLANZapine 15 MG Disintegrating Oral Tablet	PSN	dd0b2525-4e2f-44fc-9302-0ae4ebb1e135	18
351108	OLANZapine 20 MG Disintegrating Oral Tablet	PSN	dd0b2525-4e2f-44fc-9302-0ae4ebb1e135	18
314155	OLANZapine 5 MG Disintegrating Oral Tablet	PSN	dd0b2525-4e2f-44fc-9302-0ae4ebb1e135	18
312076	olanzapine 10 MG Disintegrating Oral Tablet	SCD	dd0b2525-4e2f-44fc-9302-0ae4ebb1e135	18
351107	olanzapine 15 MG Disintegrating Oral Tablet	SCD	dd0b2525-4e2f-44fc-9302-0ae4ebb1e135	18
351108	olanzapine 20 MG Disintegrating Oral Tablet	SCD	dd0b2525-4e2f-44fc-9302-0ae4ebb1e135	18
314155	olanzapine 5 MG Disintegrating Oral Tablet	SCD	dd0b2525-4e2f-44fc-9302-0ae4ebb1e135	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-5248-19	00093524819	1 in 1 BLISTER PACK						Historical
0093-5248-65	00093524865	30 BLISTER PACK in 1 CARTON (0093-5248-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5248-19)	30 blister pack	2012-02-24	0000-00-00	No	No	Current