Mirtazapine

Product NDC: 64725-1117
11-digit product format: 647251117
Labeler code: 64725
Product ID: 64725-1117_4b21397b-a3cf-4651-8b30-e80e8600e00c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TYA Pharmaceuticals
Application: ANDA076312
Marketing category: ANDA
Marketing start: 2003-06-19
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	64725-1117		I	Inactivated by FDA		2026-08-17
excluded package	package	64725-1117	64725-1117-1	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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`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	64725-1117-1	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076312-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19
A076312-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19
A076312-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`1e350fbaab3a…`

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
64725-1117-1	2019-11-27	C162847	48780-1	9855e2a2-4d3a-60a7-e053-dbdaa90a05bd	Revised: August 2014 Mirtazapine Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-1117-1	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-1117	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20140926_85f9b2ad-6f45-4625-954b-28a6d6bff517.zip

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	85f9b2ad-6f45-4625-954b-28a6d6bff517	2
311725	mirtazapine 15 MG Oral Tablet	SCD	85f9b2ad-6f45-4625-954b-28a6d6bff517	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-1117-1	64725111701	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Revised: August 2014 Mirtazapine Tablets, USP Rx only	TYA Pharmaceuticals	2014-08-21	HUMAN PRESCRIPTION DRUG LABEL	2