Mirtazapine

Product NDC: 70518-4322
Requested package NDC: 70518-4322-0
11-digit product format: 705184322
Labeler code: 70518
Product ID: 70518-4322_402edcd0-e3d3-bf53-e063-6294a90a7076
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA076122
Marketing category: ANDA
Marketing start: 2025-03-28
Substance: MIRTAZAPINE
Active strength: 15 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mirtazapine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIRTAZAPINE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
A051Q2099Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311725	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
412abf0e-1f96-4d4d-bb56-a23d4699b14c	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4322-0	Mirtazapine	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4322	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC.]	1	Current NDC, 1 package rows	20250330_412abf0e-1f96-4d4d-bb56-a23d4699b14c.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 ndc (package): 70518-4322-0 ndc (product): 70518-4322 ndc11 (package): 70518432200
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	412abf0e-1f96-4d4d-bb56-a23d4699b14c	2
311725	mirtazapine 15 MG Oral Tablet	SCD	412abf0e-1f96-4d4d-bb56-a23d4699b14c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4322-0	70518432200	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4322-0)	2025-03-28	No	No	Current