Mirtazapine

Product NDC: 13107-001
11-digit product format: 131070001
Labeler code: 13107
Product ID: 13107-001_4329eeed-8071-4b6c-887d-0cd00647b84c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurolife Pharma LLC
Application: ANDA076921
Marketing category: ANDA
Marketing start: 2009-08-17
Substance: MIRTAZAPINE
Active strength: 7.5 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 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	Approval date
A076921-001	MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22
A076921-002	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22
A076921-003	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22
A076921-004	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076921-001	AB
A076921-002	AB
A076921-003	AB
A076921-004	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`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	A076921-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIRTAZAPINE	7.5 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311725	Internal RxNorm lookup
311726	Internal RxNorm lookup
314111	Internal RxNorm lookup
476809	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
aa05d606-29fd-443e-802b-1d65584d6bb1	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	SPL version
13107-001-01	Mirtazapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	14
13107-001-05	Mirtazapine	500 in 1 BOTTLE	TABLET, FILM COATED	500	14
13107-001-30	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
13107-001-60	Mirtazapine	60 in 1 BOTTLE	TABLET, FILM COATED	60	14
13107-001-90	Mirtazapine	90 in 1 BOTTLE	TABLET, FILM COATED	90	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13107-001-05	EA - Each	13107-001	45a32c21-e565-4a76-ad48-ad95d1fa7ae0	1	2014-01-04
13107-001-30	EA - Each	13107-001	aa8a9001-6846-43f8-b9bd-6255f988db9d	1	2014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mirtazapine	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
Mirtazapine	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	7
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
HYDROXYPROPYL CELLULOSE (TYPE L)	INACTIVE INGREDIENT	UKE75GEA7F	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-001	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	13	Current NDC, Legacy NDC, 5 package rows	20240126_aa05d606-29fd-443e-802b-1d65584d6bb1.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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	Coupler LLC	598e441a-aa1a-6fb3-e063-6394a90a14aa	2026-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Redpharm Drug	58bea4d8-084f-4c30-e063-6394a90a35cb	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	10ea9d83-19c3-4f3b-a1cc-cfc48b42507f	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	9135e7db-cba4-4150-a69c-fdf2a347a785	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Preferred Pharmaceuticals Inc.	c22c4325-4f1a-4d12-8039-d3b1263fa3ad	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Preferred Pharmaceuticals Inc.	ac3716fd-6971-4a70-ae7b-9f5117f3d880	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Preferred Pharmaceuticals Inc.	2a0689ae-5650-42d1-ac9d-56dd2b467727	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	aae4c58a-5cbd-45ef-b0f9-32bf28204f15	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	American Health Packaging	82a615a0-e74a-49cb-9a57-ffbb3df604d5	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Unit Dose Solutions, Inc.	5539fe37-546b-40a8-e063-6394a90ace1b	2026-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Coupler LLC	538679a1-d474-8e1c-e063-6394a90a15d7	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Coupler LLC	53311d08-9dfa-7bb1-e063-6394a90a6656	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Coupler LLC	51269807-2b5a-e7aa-e063-6394a90ab657	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Coupler LLC	50718832-88fb-dec1-e063-6294a90ae468	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	A-S Medication Solutions	552e2261-53db-4a27-b277-f7b62c3ea2ed	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	f54718d1-3ef7-4472-9e97-90e5fd30db4d	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	6b6e946c-54b5-40e3-918f-9cc29f04cd9a	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	81d9e47e-ae81-4755-a5ee-546a038fadb4	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	7727fe84-f6cc-4b31-bc00-1ecf741ad361	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921

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
476809	mirtazapine 7.5 MG Oral Tablet	PSN	bd532a25-cfde-4c7d-8015-ba40609fb95c	103
476809	mirtazapine 7.5 MG Oral Tablet	SCD	bd532a25-cfde-4c7d-8015-ba40609fb95c	103
476809	mirtazapine 7.5 MG Oral Tablet	PSN	c2b38cc5-7738-44fa-9bef-89a18a1039b2	100
476809	mirtazapine 7.5 MG Oral Tablet	PSN	55c5905c-6cb8-4ed4-8e69-97f733ca91b5	100
476809	mirtazapine 7.5 MG Oral Tablet	SCD	c2b38cc5-7738-44fa-9bef-89a18a1039b2	100
476809	mirtazapine 7.5 MG Oral Tablet	SCD	55c5905c-6cb8-4ed4-8e69-97f733ca91b5	100
311725	mirtazapine 15 MG Oral Tablet	PSN	aa05d606-29fd-443e-802b-1d65584d6bb1	14
314111	mirtazapine 30 MG Oral Tablet	PSN	aa05d606-29fd-443e-802b-1d65584d6bb1	14
311726	mirtazapine 45 MG Oral Tablet	PSN	aa05d606-29fd-443e-802b-1d65584d6bb1	14
476809	mirtazapine 7.5 MG Oral Tablet	PSN	aa05d606-29fd-443e-802b-1d65584d6bb1	14
311725	mirtazapine 15 MG Oral Tablet	SCD	aa05d606-29fd-443e-802b-1d65584d6bb1	14
314111	mirtazapine 30 MG Oral Tablet	SCD	aa05d606-29fd-443e-802b-1d65584d6bb1	14
311726	mirtazapine 45 MG Oral Tablet	SCD	aa05d606-29fd-443e-802b-1d65584d6bb1	14
476809	mirtazapine 7.5 MG Oral Tablet	SCD	aa05d606-29fd-443e-802b-1d65584d6bb1	14
476809	mirtazapine 7.5 MG Oral Tablet	PSN	3b7a5f44-8da6-4196-bb5d-8d2770af1b3a	5
476809	mirtazapine 7.5 MG Oral Tablet	SCD	3b7a5f44-8da6-4196-bb5d-8d2770af1b3a	5
476809	mirtazapine 7.5 MG Oral Tablet	PSN	e6e5cbf7-a958-4ef8-abcc-a7491edb9520	4
476809	mirtazapine 7.5 MG Oral Tablet	SCD	e6e5cbf7-a958-4ef8-abcc-a7491edb9520	4
476809	mirtazapine 7.5 MG Oral Tablet	PSN	2990e296-2d66-70c0-e063-6394a90abbe4	1
476809	mirtazapine 7.5 MG Oral Tablet	SCD	2990e296-2d66-70c0-e063-6394a90abbe4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13107-001-01	13107000101	100 TABLET, FILM COATED in 1 BOTTLE (13107-001-01)	2009-08-17	0000-00-00	No	No	Current
13107-001-05	13107000105	500 TABLET, FILM COATED in 1 BOTTLE (13107-001-05)	2009-08-17	0000-00-00	No	No	Current
13107-001-30	13107000130	30 TABLET, FILM COATED in 1 BOTTLE (13107-001-30)	2009-08-17	0000-00-00	No	No	Current
13107-001-60	13107000160	60 TABLET, FILM COATED in 1 BOTTLE (13107-001-60)	2009-08-17	0000-00-00	No	No	Current
13107-001-90	13107000190	90 TABLET, FILM COATED in 1 BOTTLE (13107-001-90)	2009-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	Bryant Ranch Prepack	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	100
Mirtazapine	Bryant Ranch Prepack	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	103
Mirtazapine	Bryant Ranch Prepack	2025-11-04	HUMAN PRESCRIPTION DRUG LABEL	100
Mirtazapine	Aurolife Pharma LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-09-10	Human Prescription Drug Label	14
Mirtazapine	REMEDYREPACK INC.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	9
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	ATLANTIC BIOLOGICALS CORP. \| ATLANTIC BIOOGICALS CORP.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	4
Mirtazapine	American Health Packaging	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	5
Mirtazapine	Coupler LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	NCS HealthCare of KY, Inc dba Vangard Labs	2015-01-15	HUMAN PRESCRIPTION DRUG LABEL	3