Mirtazapine

Product NDC: 51079-086
11-digit product format: 510790086
Labeler code: 51079
Product ID: 51079-086_3a87423c-fbbb-b2a4-e063-6394a90a0db3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA076122
Marketing category: ANDA
Marketing start: 2003-08-01
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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311725	Internal RxNorm lookup
311726	Internal RxNorm lookup
314111	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
6837b69b-2f86-42cf-b48d-b4a3c7b5413f	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
51079-086-01	Mirtazapine	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		16
51079-086-20	Mirtazapine	100 in 1 CARTON	TABLET, FILM COATED	100		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-086-01	EA - Each	51079-086	f8b95283-c77c-4ee8-9395-7df33c66626d	1	2012-07-24
51079-086-20	EA - Each	51079-086	8b6f789c-aefe-4074-88ab-902ceae41fc7	1	2012-07-24
51079-086-56	EA - Each	51079-086	7f2bb74d-e30a-44a6-8fd6-9ca179eec998	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
AMMONIUM LAURETH-5 SULFATE	INACTIVE INGREDIENT	43ZIH89I48	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MIRTAZAPINE TABLET [CARDINAL HEALTH]	6
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51079-086	MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	15	Current NDC, Legacy NDC, 2 package rows	20241011_6837b69b-2f86-42cf-b48d-b4a3c7b5413f.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 ndc (product): 51079-086
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	6837b69b-2f86-42cf-b48d-b4a3c7b5413f	16
314111	mirtazapine 30 MG Oral Tablet	PSN	6837b69b-2f86-42cf-b48d-b4a3c7b5413f	16
311726	mirtazapine 45 MG Oral Tablet	PSN	6837b69b-2f86-42cf-b48d-b4a3c7b5413f	16
311725	mirtazapine 15 MG Oral Tablet	SCD	6837b69b-2f86-42cf-b48d-b4a3c7b5413f	16
314111	mirtazapine 30 MG Oral Tablet	SCD	6837b69b-2f86-42cf-b48d-b4a3c7b5413f	16
311726	mirtazapine 45 MG Oral Tablet	SCD	6837b69b-2f86-42cf-b48d-b4a3c7b5413f	16
311725	mirtazapine 15 MG Oral Tablet	PSN	89ae6a33-933f-47aa-a2de-2a71cd3f7d44	14
311725	mirtazapine 15 MG Oral Tablet	SCD	89ae6a33-933f-47aa-a2de-2a71cd3f7d44	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51079-086-01	51079008601	1 in 1 BLISTER PACK						Historical
51079-086-20	51079008620	100 BLISTER PACK in 1 CARTON (51079-086-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-086-01)	100 blister pack	2003-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	Mylan Institutional Inc.	2025-07-22	HUMAN PRESCRIPTION DRUG LABEL	16
Mirtazapine	Cardinal Health 107, LLC	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	14