Mirtazapine

Product NDC: 13107-003
11-digit product format: 131070003
Labeler code: 13107
Product ID: 13107-003_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: 30 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	30 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
13107-003-01	Mirtazapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	14
13107-003-05	Mirtazapine	500 in 1 BOTTLE	TABLET, FILM COATED	500	14
13107-003-30	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
13107-003-32	Mirtazapine	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	14
13107-003-34	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
13107-003-60	Mirtazapine	60 in 1 BOTTLE	TABLET, FILM COATED	60	14
13107-003-90	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
13107-003-05	EA - Each	13107-003	832bfc37-c29d-4c43-a387-b5d7c455dc8d	1	2012-07-24
13107-003-30	EA - Each	13107-003	2552ef70-db37-48c3-a1b5-394b0f69e4c0	1	2012-07-24
13107-003-34	EA - Each	13107-003	d72f67a3-cfc1-4786-aeee-7fc2f1d11a13	1	2012-07-24

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 [AMERICAN HEALTH PACKAGING]	5
Mirtazapine	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
Mirtazapine	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Mirtazapine	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
Mirtazapine	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
Mirtazapine	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
Mirtazapine	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Mirtazapine	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
Mirtazapine	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
Mirtazapine	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-003	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	13	Current NDC, Legacy NDC, 7 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
311725	mirtazapine 15 MG Oral Tablet	PSN	67e753ad-9919-416b-9e8f-aab0fa808066	21
314111	mirtazapine 30 MG Oral Tablet	PSN	67e753ad-9919-416b-9e8f-aab0fa808066	21
311725	mirtazapine 15 MG Oral Tablet	SCD	67e753ad-9919-416b-9e8f-aab0fa808066	21
314111	mirtazapine 30 MG Oral Tablet	SCD	67e753ad-9919-416b-9e8f-aab0fa808066	21
311725	mirtazapine 15 MG Oral Tablet	PSN	aa05d606-29fd-443e-802b-1d65584d6bb1	14
311725	mirtazapine 15 MG Oral Tablet	PSN	82a615a0-e74a-49cb-9a57-ffbb3df604d5	14
314111	mirtazapine 30 MG Oral Tablet	PSN	aa05d606-29fd-443e-802b-1d65584d6bb1	14
314111	mirtazapine 30 MG Oral Tablet	PSN	82a615a0-e74a-49cb-9a57-ffbb3df604d5	14
311726	mirtazapine 45 MG Oral Tablet	PSN	aa05d606-29fd-443e-802b-1d65584d6bb1	14
311726	mirtazapine 45 MG Oral Tablet	PSN	82a615a0-e74a-49cb-9a57-ffbb3df604d5	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
311725	mirtazapine 15 MG Oral Tablet	SCD	82a615a0-e74a-49cb-9a57-ffbb3df604d5	14
314111	mirtazapine 30 MG Oral Tablet	SCD	aa05d606-29fd-443e-802b-1d65584d6bb1	14
314111	mirtazapine 30 MG Oral Tablet	SCD	82a615a0-e74a-49cb-9a57-ffbb3df604d5	14
311726	mirtazapine 45 MG Oral Tablet	SCD	82a615a0-e74a-49cb-9a57-ffbb3df604d5	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
311725	mirtazapine 15 MG Oral Tablet	PSN	75dd7e5b-32ec-433b-8379-11cfb372f0d0	3
314111	mirtazapine 30 MG Oral Tablet	PSN	a96e0d95-1a7b-4588-923a-2169b5506203	3
314111	mirtazapine 30 MG Oral Tablet	PSN	75dd7e5b-32ec-433b-8379-11cfb372f0d0	3
311726	mirtazapine 45 MG Oral Tablet	PSN	75dd7e5b-32ec-433b-8379-11cfb372f0d0	3
311725	mirtazapine 15 MG Oral Tablet	SCD	75dd7e5b-32ec-433b-8379-11cfb372f0d0	3
314111	mirtazapine 30 MG Oral Tablet	SCD	a96e0d95-1a7b-4588-923a-2169b5506203	3
314111	mirtazapine 30 MG Oral Tablet	SCD	75dd7e5b-32ec-433b-8379-11cfb372f0d0	3
311726	mirtazapine 45 MG Oral Tablet	SCD	75dd7e5b-32ec-433b-8379-11cfb372f0d0	3
314111	mirtazapine 30 MG Oral Tablet	PSN	18a9c172-7081-484a-8c3b-bde9b2e54e95	2
314111	mirtazapine 30 MG Oral Tablet	PSN	411e4665-cdca-4af3-9708-2c978680b91b	2
314111	mirtazapine 30 MG Oral Tablet	SCD	18a9c172-7081-484a-8c3b-bde9b2e54e95	2
314111	mirtazapine 30 MG Oral Tablet	SCD	411e4665-cdca-4af3-9708-2c978680b91b	2
311725	mirtazapine 15 MG Oral Tablet	PSN	20a724c6-feba-40e7-a35a-8a37de2e0136	1
314111	mirtazapine 30 MG Oral Tablet	PSN	74a3f517-63eb-4e33-b75f-ef59ce14c1c8	1
314111	mirtazapine 30 MG Oral Tablet	PSN	edc62571-3808-b4b4-e053-2a95a90ab436	1
314111	mirtazapine 30 MG Oral Tablet	PSN	5aa52c22-f6b8-421c-e053-2991aa0aaf46	1
314111	mirtazapine 30 MG Oral Tablet	PSN	a8f3b8c4-1d16-93c9-e053-2a95a90aa377	1
314111	mirtazapine 30 MG Oral Tablet	PSN	54cef7d4-99d5-4863-a4fe-48e535b20f66	1
314111	mirtazapine 30 MG Oral Tablet	PSN	51269807-2b5a-e7aa-e063-6394a90ab657	1
314111	mirtazapine 30 MG Oral Tablet	PSN	20a724c6-feba-40e7-a35a-8a37de2e0136	1
311726	mirtazapine 45 MG Oral Tablet	PSN	5aa52c22-f6b8-421c-e053-2991aa0aaf46	1
311725	mirtazapine 15 MG Oral Tablet	SCD	20a724c6-feba-40e7-a35a-8a37de2e0136	1
314111	mirtazapine 30 MG Oral Tablet	SCD	edc62571-3808-b4b4-e053-2a95a90ab436	1
314111	mirtazapine 30 MG Oral Tablet	SCD	20a724c6-feba-40e7-a35a-8a37de2e0136	1
314111	mirtazapine 30 MG Oral Tablet	SCD	51269807-2b5a-e7aa-e063-6394a90ab657	1
314111	mirtazapine 30 MG Oral Tablet	SCD	a8f3b8c4-1d16-93c9-e053-2a95a90aa377	1
314111	mirtazapine 30 MG Oral Tablet	SCD	54cef7d4-99d5-4863-a4fe-48e535b20f66	1
314111	mirtazapine 30 MG Oral Tablet	SCD	5aa52c22-f6b8-421c-e053-2991aa0aaf46	1
314111	mirtazapine 30 MG Oral Tablet	SCD	74a3f517-63eb-4e33-b75f-ef59ce14c1c8	1
311726	mirtazapine 45 MG Oral Tablet	SCD	5aa52c22-f6b8-421c-e053-2991aa0aaf46	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13107-003-01	13107000301	100 TABLET, FILM COATED in 1 BOTTLE (13107-003-01)	2009-08-17	0000-00-00	No	No	Current
13107-003-05	13107000305	500 TABLET, FILM COATED in 1 BOTTLE (13107-003-05)	2009-08-17	0000-00-00	No	No	Current
13107-003-30	13107000330	30 TABLET, FILM COATED in 1 BOTTLE (13107-003-30)	2009-08-17	0000-00-00	No	No	Current
13107-003-32	13107000332	30 TABLET, FILM COATED in 1 BLISTER PACK (13107-003-32)	2009-08-17	0000-00-00	No	No	Current
13107-003-34	13107000334	30 TABLET, FILM COATED in 1 BOTTLE (13107-003-34)	2009-08-17	0000-00-00	No	No	Current
13107-003-60	13107000360	60 TABLET, FILM COATED in 1 BOTTLE (13107-003-60)	2009-08-17	0000-00-00	No	No	Current
13107-003-90	13107000390	90 TABLET, FILM COATED in 1 BOTTLE (13107-003-90)	2009-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	American Health Packaging	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	15
Mirtazapine	Coupler LLC	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine	A-S Medication Solutions	2026-01-14	Human Prescription Drug Label	21
Mirtazapine	Aurolife Pharma LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-09-10	Human Prescription Drug Label	14
Mirtazapine	RPK Pharmaceuticals, Inc.	2023-11-23	Human Prescription Drug Label	1
Mirtazapine	NuCare Pharmaceuticals,Inc.	2022-11-18	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	2
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2020-06-25	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2019-12-18	Human Prescription Drug Label	3
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	NCS HealthCare of KY, Inc dba Vangard Labs	2019-03-08	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	A-S Medication Solutions	2019-02-08	Human Prescription Drug Label	1
484 Mirtazapine 30 mg 478 Mirtazapine 45 mg Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2017-10-03	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	TYA Pharmaceuticals	2013-12-16	Human Prescription Drug Label	2
Mirtazapine Tablets, USP 30 mg Rx Only	H.J. Harkins Company, Inc. \| Aurolife Pharma LLC	2011-12-20	Human Prescription Drug Label	2