mirtazapine

Product NDC: 70771-1074
11-digit product format: 707711074
Labeler code: 70771
Product ID: 70771-1074_6c3c6185-e272-46c5-85da-24a457efc412
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mirtazapine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Cadila Healthcare Limited
Application: ANDA205798
Marketing category: ANDA
Marketing start: 2017-07-20
Marketing end: 0000-00-00
Substance: MIRTAZAPINE
Active strength: 45 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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	70771-1074		D	Discontinued by firm		2026-08-07
excluded package	package	70771-1074	70771-1074-4	D	Discontinued by firm		2026-08-07

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 · 24 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	70771-1074-4	`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	70771-1074-4	`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	70771-1074-4	`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	70771-1074-4	`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	70771-1074-4	`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	70771-1074-4	`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	70771-1074-4	`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	70771-1074-4	`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	70771-1074-4	`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	70771-1074-4	`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	70771-1074-4	`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	70771-1074-4	`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
A205798-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01
A205798-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01
A205798-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205798-001	AB
A205798-002	AB
A205798-003	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	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`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	A205798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205798-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205798-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	Viona Pharmaceuticals Inc.	ed491abe-9412-428b-8e24-57242862c99a	2025-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205798 application number: ANDA205798
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	c47428e5-4717-4471-9231-ec8b5438205a	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205798 application number: ANDA205798
Mirtazapine	MIRTAZAPINE	SQUARE PHARMACEUTICALS LIMITED	83093852-d212-408e-98fd-33f4603a9d65	2023-07-02		Exact identifier application applno (ANDA): 205798 application number: ANDA205798

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70771-1074-4	70771107404	30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (70771-1074-4)	2017-07-20	0000-00-00	No	No	Current