Olanzapine

Product NDC: 67046-525
11-digit product format: 670460525
Labeler code: 67046
Product ID: 67046-525_5abc92df-b330-c421-e053-2a91aa0a109d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA202862
Marketing category: ANDA
Marketing start: 2017-10-04
Marketing end: 0000-00-00
Substance: OLANZAPINE
Active strength: 10 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67046-525		I	Inactivated by FDA	2026-08-17
excluded package	package	67046-525	67046-525-07	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-525	67046-525-14	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-525	67046-525-15	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-525	67046-525-20	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-525	67046-525-21	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-525	67046-525-28	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-525	67046-525-30	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-525	67046-525-60	I	Inactivated by FDA	2026-08-17

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 4 · 189 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	67046-525-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-525-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-525-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-525-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-525-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-525-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-525-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-525-14	`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	67046-525-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-525-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-525-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-525-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-525-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-525-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-525-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-525-14	`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	67046-525-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-525-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-525-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-525-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-525-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-525-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-525-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-525-14	`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	67046-525-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-525-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-525-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-525-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-525-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-525-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-525-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-525-14	`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	67046-525-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-525-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-525-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-525-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-525-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-525-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-525-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-525-14	`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	67046-525-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-525-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-525-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-525-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-525-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-525-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-525-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-525-14	`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	67046-525-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-525-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-525-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-525-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-525-28	`302b2466d912…`	`e7b80fea0513…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202862-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15
A202862-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15
A202862-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15
A202862-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15
A202862-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15
A202862-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202862-001	AB
A202862-002	AB
A202862-003	AB
A202862-004	AB
A202862-005	AB
A202862-006	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 · 252 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
2026-08-18 06:07:40	2026-07	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202862-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202862-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202862-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-004	AB	1	`03ed91905a0d…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67046-525-07	525 Olanzapine 10 mg These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets for oral use Initial U.S. Approval: 1996
67046-525-14	525 Olanzapine 10 mg These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets for oral use Initial U.S. Approval: 1996
67046-525-15	525 Olanzapine 10 mg These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets for oral use Initial U.S. Approval: 1996
67046-525-20	525 Olanzapine 10 mg These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets for oral use Initial U.S. Approval: 1996
67046-525-21	525 Olanzapine 10 mg These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets for oral use Initial U.S. Approval: 1996
67046-525-28	525 Olanzapine 10 mg These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets for oral use Initial U.S. Approval: 1996
67046-525-30	525 Olanzapine 10 mg These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets for oral use Initial U.S. Approval: 1996
67046-525-60	525 Olanzapine 10 mg These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67046-525-07	Olanzapine	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	1
67046-525-14	Olanzapine	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	1
67046-525-15	Olanzapine	15 in 1 BLISTER PACK	TABLET, FILM COATED	15	1
67046-525-20	Olanzapine	20 in 1 BLISTER PACK	TABLET, FILM COATED	20	1
67046-525-21	Olanzapine	21 in 1 BLISTER PACK	TABLET, FILM COATED	21	1
67046-525-28	Olanzapine	28 in 1 BLISTER PACK	TABLET, FILM COATED	28	1
67046-525-30	Olanzapine	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	1
67046-525-60	Olanzapine	60 in 1 BLISTER PACK	TABLET, FILM COATED	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-525	OLANZAPINE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1	Legacy NDC, 8 package rows	20171004_5abc92df-b32f-c421-e053-2a91aa0a109d.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	5bded04a-d848-4ac6-b7c3-ff9b9fef3d29	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	9eb6b0d1-b301-4847-88f5-f8613d550ecc	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	PD-Rx Pharmaceuticals, Inc.	b6f0b2e2-3cbd-4564-8b3e-f811589af275	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	8e5ef52d-315b-4055-9e52-403e6f896f24	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Redpharm Drug	54adae9e-6781-6a77-e063-6394a90ab5c8	2026-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Coupler LLC	549dc142-adcd-99ed-e063-6294a90a37fa	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Coupler LLC	52bdaaaf-ab54-99d1-e063-6394a90a521f	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Coupler LLC	518a9400-edb8-6403-e063-6294a90a065d	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	76a6ff21-7157-4213-8073-35837a3ac07e	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Macleods Pharmaceuticals Limited	8e095987-bdea-42f2-9550-c7155cf07d30	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	88edb3fc-fcb6-4483-859d-f830b077aca2	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	f6fd7ceb-1457-4c3e-9d30-4f658f39d37d	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	c47f90fc-49fe-4f60-9da8-1365a1650dd9	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	dcf8fcbf-636c-41ad-8084-c65ac2f117cc	2025-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	8586e828-34e7-4eb4-a933-6c688927478f	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	NCS HealthCare of KY, LLC dba Vangard Labs	87b7fb23-c9b7-433f-bd17-cd3e91714c27	2025-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Direct_Rx	fcec190f-b865-c5d3-e053-6394a90a7e45	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Direct_Rx	22528ae1-e36f-48e1-e063-6294a90a3dd2	2024-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	NorthStar RxLLC	ea3259d5-36ee-4ac9-b849-9625626e2187	2024-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Proficient Rx LP	ce66d545-015b-41d5-80c3-964d78e36bfd	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862

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	5abc92df-b32f-c421-e053-2a91aa0a109d	1
314154	olanzapine 10 MG Oral Tablet	SCD	5abc92df-b32f-c421-e053-2a91aa0a109d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67046-525-07	67046052507	7 in 1 BLISTER PACK	Historical
67046-525-14	67046052514	14 in 1 BLISTER PACK	Historical
67046-525-15	67046052515	15 in 1 BLISTER PACK	Historical
67046-525-20	67046052520	20 in 1 BLISTER PACK	Historical
67046-525-21	67046052521	21 in 1 BLISTER PACK	Historical
67046-525-28	67046052528	28 in 1 BLISTER PACK	Historical
67046-525-30	67046052530	30 in 1 BLISTER PACK	Historical
67046-525-60	67046052560	60 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olanzapine	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2017-10-04	HUMAN PRESCRIPTION DRUG LABEL	1