OLANZAPINE

Product NDC: 13668-167
11-digit product format: 136680167
Labeler code: 13668
Product ID: 13668-167_1a64829a-2434-4c8d-8e58-9b28758e4b88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OLANZAPINE
Dosage form: TABLET
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA091434
Marketing category: ANDA
Marketing start: 2026-02-28
Substance: OLANZAPINE
Active strength: 5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 2 · 84 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	13668-167-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-167-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-167-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-167-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-167-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-167-10	`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	13668-167-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-167-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-167-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-167-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-167-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-167-10	`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	13668-167-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-167-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-167-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-167-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-167-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-167-10	`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	13668-167-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-167-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-167-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-167-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-167-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-167-10	`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	13668-167-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-167-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-167-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-167-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-167-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-167-10	`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	13668-167-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-167-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-167-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-167-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-167-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-167-10	`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	13668-167-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-167-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-167-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-167-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-167-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-167-10	`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	13668-167-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-167-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-167-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-167-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-167-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-167-10	`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	13668-167-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-167-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-167-60	`0efc9e666f02…`	`f202fb6c5f17…`

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
A091434-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23
A091434-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23
A091434-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23
A091434-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23
A091434-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23
A091434-006	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
A091434-001	AB
A091434-002	AB
A091434-003	AB
A091434-004	AB
A091434-005	AB
A091434-006	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	A091434-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091434-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091434-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091434-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091434-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091434-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091434-001	OLANZAPINE	2.5MG	TABLET / ORAL		2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091434-002	OLANZAPINE	5MG	TABLET / ORAL		2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091434-003	OLANZAPINE	7.5MG	TABLET / ORAL		2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091434-004	OLANZAPINE	10MG	TABLET / ORAL		2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091434-005	OLANZAPINE	15MG	TABLET / ORAL		2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091434-006	OLANZAPINE	20MG	TABLET / ORAL		2012-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091434-001	OLANZAPINE	2.5MG	TABLET / ORAL		2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091434-002	OLANZAPINE	5MG	TABLET / ORAL		2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091434-003	OLANZAPINE	7.5MG	TABLET / ORAL		2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091434-004	OLANZAPINE	10MG	TABLET / ORAL		2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091434-005	OLANZAPINE	15MG	TABLET / ORAL		2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091434-006	OLANZAPINE	20MG	TABLET / ORAL		2012-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091434-001	OLANZAPINE	2.5MG	TABLET / ORAL		2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091434-002	OLANZAPINE	5MG	TABLET / ORAL		2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091434-003	OLANZAPINE	7.5MG	TABLET / ORAL		2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091434-004	OLANZAPINE	10MG	TABLET / ORAL		2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091434-005	OLANZAPINE	15MG	TABLET / ORAL		2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091434-006	OLANZAPINE	20MG	TABLET / ORAL		2012-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091434-001	OLANZAPINE	2.5MG	TABLET / ORAL		2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091434-002	OLANZAPINE	5MG	TABLET / ORAL		2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091434-003	OLANZAPINE	7.5MG	TABLET / ORAL		2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091434-004	OLANZAPINE	10MG	TABLET / ORAL		2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091434-005	OLANZAPINE	15MG	TABLET / ORAL		2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091434-006	OLANZAPINE	20MG	TABLET / ORAL		2012-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091434-001	OLANZAPINE	2.5MG	TABLET / ORAL		2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091434-002	OLANZAPINE	5MG	TABLET / ORAL		2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091434-003	OLANZAPINE	7.5MG	TABLET / ORAL		2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091434-004	OLANZAPINE	10MG	TABLET / ORAL		2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091434-005	OLANZAPINE	15MG	TABLET / ORAL		2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091434-006	OLANZAPINE	20MG	TABLET / ORAL		2012-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091434-001	OLANZAPINE	2.5MG	TABLET / ORAL		2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091434-002	OLANZAPINE	5MG	TABLET / ORAL		2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091434-003	OLANZAPINE	7.5MG	TABLET / ORAL		2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091434-004	OLANZAPINE	10MG	TABLET / ORAL		2012-04-23	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 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	A091434-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091434-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091434-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091434-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091434-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091434-006	AB	1	`011fe1cb6892…`
2019-12-13 00:20 UTC	2019-12	A091434-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091434-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091434-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091434-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091434-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091434-006	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A091434-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091434-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091434-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091434-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091434-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091434-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091434-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091434-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091434-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091434-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091434-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091434-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091434-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091434-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091434-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091434-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091434-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091434-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091434-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091434-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091434-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091434-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091434-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091434-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091434-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091434-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091434-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091434-004	AB	1	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLANZAPINE	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 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200034	Internal RxNorm lookup
283639	Internal RxNorm lookup
312076	Internal RxNorm lookup
312077	Internal RxNorm lookup
312078	Internal RxNorm lookup
312079	Internal RxNorm lookup
314154	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
2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
12d02c27-e8da-47f1-b815-ccca982731ef	Product name	9	20170802
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13668-167-01	OLANZAPINE	100 in 1 BOTTLE	TABLET	100	19
13668-167-05	OLANZAPINE	500 in 1 BOTTLE	TABLET	500	19
13668-167-10	OLANZAPINE	1000 in 1 BOTTLE	TABLET	1000	19
13668-167-20	OLANZAPINE	2000 in 1 BOTTLE	TABLET	2000	19
13668-167-30	OLANZAPINE	30 in 1 BOTTLE	TABLET	30	19
13668-167-60	OLANZAPINE	60 in 1 BOTTLE	TABLET	60	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-167-01	EA - Each	13668-167	b737f2b4-2760-45cc-be33-09579bbfe0d0	1	2012-07-24
13668-167-10	EA - Each	13668-167	d99ed28e-8c45-47c5-b60a-4fc79dd9306b	1	2012-07-24
13668-167-30	EA - Each	13668-167	49afb2cd-88ec-4b7b-93de-8c5b8523425c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OLANZAPINE	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]	6
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]	6
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-167	OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]	17	Current NDC, Legacy NDC, 6 package rows	20250305_2cb1bebe-0ced-46d8-bf21-c28a9acc4a15.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	Torrent Pharmaceuticals Limited	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091434 application number: ANDA091434 ndc (product): 13668-167

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	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
314154	OLANZapine 10 MG Oral Tablet	PSN	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
351107	OLANZapine 15 MG Disintegrating Oral Tablet	PSN	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
312077	OLANZapine 15 MG Oral Tablet	PSN	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
200034	OLANZapine 2.5 MG Oral Tablet	PSN	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
351108	OLANZapine 20 MG Disintegrating Oral Tablet	PSN	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
283639	OLANZapine 20 MG Oral Tablet	PSN	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
314155	OLANZapine 5 MG Disintegrating Oral Tablet	PSN	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
312078	OLANZapine 5 MG Oral Tablet	PSN	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
312079	OLANZapine 7.5 MG Oral Tablet	PSN	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
312076	olanzapine 10 MG Disintegrating Oral Tablet	SCD	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
314154	olanzapine 10 MG Oral Tablet	SCD	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
351107	olanzapine 15 MG Disintegrating Oral Tablet	SCD	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
312077	olanzapine 15 MG Oral Tablet	SCD	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
200034	olanzapine 2.5 MG Oral Tablet	SCD	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
351108	olanzapine 20 MG Disintegrating Oral Tablet	SCD	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
283639	olanzapine 20 MG Oral Tablet	SCD	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
314155	olanzapine 5 MG Disintegrating Oral Tablet	SCD	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
312078	olanzapine 5 MG Oral Tablet	SCD	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19
312079	olanzapine 7.5 MG Oral Tablet	SCD	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-167-01	13668016701	100 TABLET in 1 BOTTLE (13668-167-01)	100 tablet	2026-02-28	2021-02-28	No	No	Current
13668-167-05	13668016705	500 TABLET in 1 BOTTLE (13668-167-05)	500 tablet	2026-02-28	2021-02-28	No	No	Current
13668-167-10	13668016710	1000 TABLET in 1 BOTTLE (13668-167-10)	1000 tablet	2026-02-28	2021-02-28	No	No	Current
13668-167-20	13668016720	2000 TABLET in 1 BOTTLE (13668-167-20)	2000 tablet	2026-02-28	2021-02-28	No	No	Current
13668-167-30	13668016730	30 TABLET in 1 BOTTLE (13668-167-30)	30 tablet	2026-02-28	2021-02-28	No	No	Current
13668-167-60	13668016760	60 TABLET in 1 BOTTLE (13668-167-60)	60 tablet	2026-02-28	2021-02-28	No	No	Current
13668-167-74	13668016774	100 TABLET in 1 CARTON (13668-167-74)	100 tablet	2012-04-23	2021-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OLANZAPINE	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	19