Mirtazapine

Product NDC: 53808-0735
11-digit product format: 538080735
Labeler code: 53808
Product ID: 53808-0735_63cbcedb-7dfd-4ec5-ae64-d6c87e1b2b5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MIRTAZAPINE
Dosage form: TABLET
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA076541
Marketing category: ANDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: MIRTAZAPINE
Active strength: 15 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0735		I	Inactivated by FDA		2026-08-17
excluded package	package	53808-0735	53808-0735-1	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 1 · 44 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	53808-0735-1	`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	53808-0735-1	`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	53808-0735-1	`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	53808-0735-1	`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	53808-0735-1	`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	53808-0735-1	`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	53808-0735-1	`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	53808-0735-1	`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	53808-0735-1	`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	53808-0735-1	`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	53808-0735-1	`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	53808-0735-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0735-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0735-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0735-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0735-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0735-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0735-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0735-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0735-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0735-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0735-1	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076541-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22
A076541-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22
A076541-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22
A076541-004	MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076541-001	AB
A076541-002	AB
A076541-003	AB
A076541-004	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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A076541-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076541-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076541-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076541-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076541-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076541-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-004	AB	1	`d8e5a09893c0…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0735-1	2019-10-21	C162847	48780-1	956f9ecf-c8af-621f-e053-dbdaa90a74ad	4801d296-7194-4c8c-895d-0dc1a3e6eb25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0735-1	Mirtazapine	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0735	MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100614_4801d296-7194-4c8c-895d-0dc1a3e6eb25.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	577c3ceb-316b-4c93-9b0c-0a4b1b4773e9	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	e708e8bb-9b13-44d9-96f5-fd73a893a987	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	356eb045-6347-49cc-818e-65b1cdff8f4e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	AvKARE	e5478a6a-a29a-9f61-e053-2995a90a11d0	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	3bb242b0-42ed-471a-b3c4-5ded1e292e80	2024-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	8c03eb2b-6aed-40a1-a424-67ac1ab6085d	2024-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	ecf7826c-c583-4836-9b00-bf9e4b51a144	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	ded5b83b-f11a-4a6a-bf77-c5fe6dc4c4f5	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	9f0f52e8-3318-4da2-b0d9-ea3d33bfe41e	2023-10-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	1ba111d1-cf92-4cd9-afcb-3bebd1bacd46	2023-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	50ccc34a-4b89-4b07-b153-6c71c6924db1	2023-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Sun Pharmaceutical Industries, Inc.	f23631be-c7ae-46e9-b771-a70be17bc9f0	2021-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541

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	4801d296-7194-4c8c-895d-0dc1a3e6eb25	1
314111	mirtazapine 30 MG Oral Tablet	PSN	4801d296-7194-4c8c-895d-0dc1a3e6eb25	1
311726	mirtazapine 45 MG Oral Tablet	PSN	4801d296-7194-4c8c-895d-0dc1a3e6eb25	1
311725	mirtazapine 15 MG Oral Tablet	SCD	4801d296-7194-4c8c-895d-0dc1a3e6eb25	1
314111	mirtazapine 30 MG Oral Tablet	SCD	4801d296-7194-4c8c-895d-0dc1a3e6eb25	1
311726	mirtazapine 45 MG Oral Tablet	SCD	4801d296-7194-4c8c-895d-0dc1a3e6eb25	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0735-1	53808073501	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2010-05-28	HUMAN PRESCRIPTION DRUG LABEL	1