OLANZAPINE

Product NDC: 35573-423
Requested package NDC: 35573-423-30
11-digit product format: 355730423
Labeler code: 35573
Product ID: 35573-423_eda6b4a9-342f-4efa-b002-79ce056d4219
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olanzapine
Dosage form: TABLET
Route: ORAL
Labeler: Burel Pharmaceuticals, LLC
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	35573-423	35573-423-30	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 · 9 matching rows.

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

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

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
35573-423-30	35573042330	30 TABLET in 1 BOTTLE (35573-423-30)	30 tablet	2012-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OLANZAPINE	Burel Pharmaceuticals, LLC \| Aurolife Pharma, LLC \| Aurobindo Pharma Limited	2021-06-25	Human Prescription Drug Label	1