Olanzapine

Product NDC: 60505-3110
11-digit product format: 605053110
Labeler code: 60505
Product ID: 60505-3110_2dd39227-59ef-df97-a57e-d5a013dc132f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA090798
Marketing category: ANDA
Marketing start: 2012-04-23
Substance: OLANZAPINE
Active strength: 2.5 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090798-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23
A090798-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23
A090798-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23
A090798-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23
A090798-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23
A090798-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090798-001	AB
A090798-002	AB
A090798-003	AB
A090798-004	AB
A090798-005	AB
A090798-006	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 · 246 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	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A090798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLANZAPINE	2.5 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
3347d1c8-04c9-5ce1-8cda-b38e0412b709	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
60505-3110-0	Olanzapine	10 in 1 CARTON	TABLET, FILM COATED	10	13
60505-3110-0	Olanzapine	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	13
60505-3110-3	Olanzapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	13
60505-3110-8	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
60505-3110-0	EA - Each	60505-3110	1d062835-9f6f-4dd6-9c91-4e531e518847	1	2012-07-24
60505-3110-3	EA - Each	60505-3110	88fd2249-0573-4c4b-ac9b-64f3c3e6c381	1	2012-07-24
60505-3110-8	EA - Each	60505-3110	d68c2cb3-756d-4b02-9947-75f4be699ba7	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
Fd&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
Hypromellose 2910 (6 Mpa.S)	INACTIVE INGREDIENT	0WZ8WG20P6	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
Polyethylene Glycol 1000	INACTIVE INGREDIENT	U076Q6Q621	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	2
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-3110	OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]	12	Current NDC, Legacy NDC, 4 package rows	20250411_3347d1c8-04c9-5ce1-8cda-b38e0412b709.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	e830f488-c689-40f6-9351-f9c7454ff1ea	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	032e589c-47b1-4eb1-9466-8160297b81e9	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Golden State Medical Supply, Inc.	a1dfb4e7-4143-4422-b7a7-292e4fd75044	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Apotex Corp.	3347d1c8-04c9-5ce1-8cda-b38e0412b709	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798 ndc (product): 60505-3110
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	1866a03c-eac9-44a1-8f33-7dc6e8a8c06a	2025-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Proficient Rx LP	024e8e9b-a4fc-4882-b080-c070467166a6	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Proficient Rx LP	e40d54bf-7334-4418-8a87-ff85941adec1	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Aphena Pharma Solutions - Tennessee, LLC	b6ec5610-b4a6-4646-954a-0fe8b1d3e143	2020-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Proficient Rx LP	7772a4c2-1fb1-412b-9e3b-ef3d693517a2	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798

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	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
312077	OLANZapine 15 MG Oral Tablet	PSN	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
200034	OLANZapine 2.5 MG Oral Tablet	PSN	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
283639	OLANZapine 20 MG Oral Tablet	PSN	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
312078	OLANZapine 5 MG Oral Tablet	PSN	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
312079	OLANZapine 7.5 MG Oral Tablet	PSN	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
314154	olanzapine 10 MG Oral Tablet	SCD	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
312077	olanzapine 15 MG Oral Tablet	SCD	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
200034	olanzapine 2.5 MG Oral Tablet	SCD	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
283639	olanzapine 20 MG Oral Tablet	SCD	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
312078	olanzapine 5 MG Oral Tablet	SCD	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
312079	olanzapine 7.5 MG Oral Tablet	SCD	3347d1c8-04c9-5ce1-8cda-b38e0412b709	13
314154	OLANZapine 10 MG Oral Tablet	PSN	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
312077	OLANZapine 15 MG Oral Tablet	PSN	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
200034	OLANZapine 2.5 MG Oral Tablet	PSN	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
283639	OLANZapine 20 MG Oral Tablet	PSN	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
312078	OLANZapine 5 MG Oral Tablet	PSN	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
312079	OLANZapine 7.5 MG Oral Tablet	PSN	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
314154	olanzapine 10 MG Oral Tablet	SCD	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
312077	olanzapine 15 MG Oral Tablet	SCD	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
200034	olanzapine 2.5 MG Oral Tablet	SCD	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
283639	olanzapine 20 MG Oral Tablet	SCD	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
312078	olanzapine 5 MG Oral Tablet	SCD	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
312079	olanzapine 7.5 MG Oral Tablet	SCD	a1dfb4e7-4143-4422-b7a7-292e4fd75044	12
200034	OLANZapine 2.5 MG Oral Tablet	PSN	032e589c-47b1-4eb1-9466-8160297b81e9	6
200034	olanzapine 2.5 MG Oral Tablet	SCD	032e589c-47b1-4eb1-9466-8160297b81e9	6
314154	OLANZapine 10 MG Oral Tablet	PSN	e40d54bf-7334-4418-8a87-ff85941adec1	4
200034	OLANZapine 2.5 MG Oral Tablet	PSN	e40d54bf-7334-4418-8a87-ff85941adec1	4
314154	olanzapine 10 MG Oral Tablet	SCD	e40d54bf-7334-4418-8a87-ff85941adec1	4
200034	olanzapine 2.5 MG Oral Tablet	SCD	e40d54bf-7334-4418-8a87-ff85941adec1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-3110-0	60505311000	10 BLISTER PACK in 1 CARTON (60505-3110-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2012-04-23	0000-00-00	No	No	Current
60505-3110-3	60505311003	30 TABLET, FILM COATED in 1 BOTTLE (60505-3110-3)		2012-04-23	0000-00-00	No	No	Current
60505-3110-8	60505311008	1000 TABLET, FILM COATED in 1 BOTTLE (60505-3110-8)		2012-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olanzapine	REMEDYREPACK INC.	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	7
Olanzapine	Golden State Medical Supply, Inc.	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	12
Olanzapine	Apotex Corp.	2025-11-18	HUMAN PRESCRIPTION DRUG LABEL	13
Olanzapine	Bryant Ranch Prepack	2025-05-20	HUMAN PRESCRIPTION DRUG LABEL	102
Olanzapine	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Olanzapine	AvPAK	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	3