Mirtazapine

Product NDC: 43353-962
11-digit product format: 433530962
Labeler code: 43353
Product ID: 43353-962_9a4d6413-815d-46e3-b9df-680c2671567c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076122
Marketing category: ANDA
Marketing start: 2012-12-28
Marketing end: 0000-00-00
Substance: MIRTAZAPINE
Active strength: 30 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-962		I	Inactivated by FDA	2026-08-11
excluded package	package	43353-962	43353-962-15	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-962	43353-962-30	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-962	43353-962-45	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-962	43353-962-53	I	Inactivated by FDA	2026-08-11

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 · 75 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	43353-962-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-962-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-962-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-962-53	`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	43353-962-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-962-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-962-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-962-53	`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	43353-962-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-962-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-962-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-962-53	`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	43353-962-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-962-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-962-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-962-53	`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	43353-962-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-962-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-962-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-962-53	`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	43353-962-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-962-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-962-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-962-53	`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	43353-962-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-962-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-962-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-962-53	`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	43353-962-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-962-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-962-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-962-53	`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	43353-962-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-962-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-962-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-962-53	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-962-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-962-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-962-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-962-53	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-962-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-962-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-962-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-962-53	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-962-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-962-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-962-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-962-53	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076122-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19
A076122-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19
A076122-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076122-001	AB
A076122-002	AB
A076122-003	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 4 · 123 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	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076122-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076122-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076122-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-06-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A076122-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076122-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076122-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076122-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076122-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076122-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076122-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076122-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076122-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076122-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076122-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076122-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076122-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076122-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076122-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076122-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076122-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076122-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076122-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076122-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076122-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076122-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076122-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076122-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076122-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076122-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076122-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076122-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076122-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076122-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076122-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076122-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076122-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076122-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076122-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076122-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076122-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076122-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076122-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076122-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ca5a24a-fafa-8fc8-52ac-b403ff18faa5	Product name	3	20240216
a733d273-402b-1005-9891-1ac1a9c63703	Product name	2	20170724

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-962-15	03395e21-ea63-4a4b-b1e0-418c414a35fc
43353-962-30	03395e21-ea63-4a4b-b1e0-418c414a35fc
43353-962-45	03395e21-ea63-4a4b-b1e0-418c414a35fc
43353-962-53	03395e21-ea63-4a4b-b1e0-418c414a35fc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-962-15	Mirtazapine	15 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	15	2
43353-962-30	Mirtazapine	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	2
43353-962-45	Mirtazapine	45 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	45	2
43353-962-53	Mirtazapine	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-962-15	EA - Each	43353-962	6b4a0516-8e82-4d91-8e69-952cb3008c34	1	2016-07-19
43353-962-30	EA - Each	43353-962	f53470a9-3bb7-4a0b-84cc-7787e6ba1794	1	2016-07-19
43353-962-45	EA - Each	43353-962	e8aa0321-83df-473e-aca9-b5e738f3fd9c	1	2016-07-19
43353-962-53	EA - Each	43353-962	b42bb99a-e864-4856-8638-fb7c31d9944c	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-962	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 4 package rows	20191224_03395e21-ea63-4a4b-b1e0-418c414a35fc.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
Mirtazapine	MIRTAZAPINE	Cardinal Health 107, LLC	7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076122 application number: ANDA076122
Mirtazapine	MIRTAZAPINE	Safecor Health LLC	6d2ff278-0c80-4373-b77d-b5f186c4b991	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076122 application number: ANDA076122
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	412abf0e-1f96-4d4d-bb56-a23d4699b14c	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076122 application number: ANDA076122
Mirtazapine	MIRTAZAPINE	Mylan Institutional Inc.	6837b69b-2f86-42cf-b48d-b4a3c7b5413f	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076122 application number: ANDA076122
Mirtazapine	MIRTAZAPINE	Cardinal Health 107, LLC	89ae6a33-933f-47aa-a2de-2a71cd3f7d44	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076122 application number: ANDA076122
Mirtazapine	MIRTAZAPINE	Golden State Medical Supply, Inc.	a6a5949f-5ebf-f37d-e053-2995a90adae5	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076122 application number: ANDA076122
Mirtazapine	MIRTAZAPINE	Mylan Pharmaceuticals Inc.	711aa80b-8fc6-49e6-9494-3db31d9b53a4	2022-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076122 application number: ANDA076122
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	500dbfbe-2a00-496d-9e44-6e59d2c68ea2	2021-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076122 application number: ANDA076122
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	93c4ddcf-ca4f-4a46-a7b7-1395fb0885d2	2020-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076122 application number: ANDA076122

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A051Q2099Q	MIRTAZAPINE	85650-52-8	MIRTAZAPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311725	mirtazapine 15 MG Oral Tablet	PSN	03395e21-ea63-4a4b-b1e0-418c414a35fc	2
314111	mirtazapine 30 MG Oral Tablet	PSN	03395e21-ea63-4a4b-b1e0-418c414a35fc	2
311725	mirtazapine 15 MG Oral Tablet	SCD	03395e21-ea63-4a4b-b1e0-418c414a35fc	2
314111	mirtazapine 30 MG Oral Tablet	SCD	03395e21-ea63-4a4b-b1e0-418c414a35fc	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-962-15	43353096215	15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-962-15)	2014-09-16	0000-00-00	No	No	Current
43353-962-30	43353096230	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-962-30)	2014-09-10	0000-00-00	No	No	Current
43353-962-45	43353096245	45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-962-45)	2014-09-19	0000-00-00	No	No	Current
43353-962-53	43353096253	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-962-53)	2014-09-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2016-06-21	HUMAN PRESCRIPTION DRUG LABEL	2