OLANZAPINE

Product NDC: 66993-681
11-digit product format: 669930681
Labeler code: 66993
Product ID: 66993-681_257af069-b3dd-4a9f-938e-fcff35e4c9cd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olanzapine
Dosage form: TABLET
Route: ORAL
Labeler: Prasco Laboratories
Application: ANDA202050
Marketing category: ANDA
Marketing start: 2012-04-23
Marketing end: 0000-00-00
Substance: OLANZAPINE
Active strength: 5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66993-681		D	Discontinued by firm	2026-10-05
excluded package	package	66993-681	66993-681-05	D	Discontinued by firm	2026-10-05
excluded package	package	66993-681	66993-681-30	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66993-681-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66993-681-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66993-681-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66993-681-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66993-681-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66993-681-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66993-681-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66993-681-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66993-681-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66993-681-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66993-681-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66993-681-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66993-681-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66993-681-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66993-681-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66993-681-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66993-681-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66993-681-05	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202050-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23
A202050-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23
A202050-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23
A202050-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23
A202050-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23
A202050-006	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
A202050-001	AB
A202050-002	AB
A202050-003	AB
A202050-004	AB
A202050-005	AB
A202050-006	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 · 258 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	A202050-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202050-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202050-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202050-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202050-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202050-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202050-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202050-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202050-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202050-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202050-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202050-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202050-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202050-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202050-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202050-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202050-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202050-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202050-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202050-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202050-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202050-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202050-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202050-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202050-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202050-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202050-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202050-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 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	A202050-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202050-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202050-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202050-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202050-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202050-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202050-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202050-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202050-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202050-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202050-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202050-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202050-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202050-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202050-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202050-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202050-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202050-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202050-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202050-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202050-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202050-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202050-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202050-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202050-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202050-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202050-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202050-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202050-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202050-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-681-30	EA - Each	66993-681	d70e0c8b-8a7c-4522-a8ed-22b4b3daacae	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE TABLET [PRASCO LABORATORIES]	1
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE TABLET [PRASCO LABORATORIES]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OLANZAPINE TABLET [PRASCO LABORATORIES]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	OLANZAPINE TABLET [PRASCO LABORATORIES]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OLANZAPINE TABLET [PRASCO LABORATORIES]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE TABLET [PRASCO LABORATORIES]	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	4e90e30c-78a1-486f-a13c-f1ff798216be	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202050 application number: ANDA202050
Olanzapine	OLANZAPINE	Aurobindo Pharma Limited	636665be-9d7e-443a-8134-e8cc47e6ba24	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202050 application number: ANDA202050

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
66993-681-30	66993068130	30 TABLET in 1 BOTTLE (66993-681-30)	30 tablet	2012-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OLANZAPINE	REMEDYREPACK INC.	2024-03-07	HUMAN PRESCRIPTION DRUG LABEL	5
OLANZAPINE	Prasco Laboratories \| Aurolife Pharma, LLC \| Aurobindo Pharma Limited	2020-12-25	Human Prescription Drug Label	8