Mirtazapine

Product NDC: 13107-031
11-digit product format: 131070031
Labeler code: 13107
Product ID: 13107-031_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: 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 · 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A076921-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076921-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076921-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076921-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Mirtazapine	MIRTAZAPINE	A-S Medication Solutions	67e753ad-9919-416b-9e8f-aab0fa808066	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	d1b59d87-8442-4c15-8bb9-e39b198d8677	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921

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 · 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
13107-031-01	Mirtazapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	14
13107-031-05	Mirtazapine	500 in 1 BOTTLE	TABLET, FILM COATED	500	14
13107-031-30	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
13107-031-32	Mirtazapine	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	14
13107-031-34	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
13107-031-60	Mirtazapine	60 in 1 BOTTLE	TABLET, FILM COATED	60	14
13107-031-90	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
13107-031-05	EA - Each	13107-031	84c341d9-10f7-4255-84f4-26c9903ab83d	1	2012-07-24
13107-031-30	EA - Each	13107-031	4e545c96-ecde-4a27-96ce-7e96563d07d3	1	2012-07-24
13107-031-34	EA - Each	13107-031	404a7f5b-d899-4fd7-ac56-2d74a266fb09	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 MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	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
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
Mirtazapine	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
Mirtazapine	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-031	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	13	Current NDC, Legacy NDC, 7 package rows	20240126_aa05d606-29fd-443e-802b-1d65584d6bb1.zip

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	82a615a0-e74a-49cb-9a57-ffbb3df604d5	14
311725	mirtazapine 15 MG Oral Tablet	PSN	aa05d606-29fd-443e-802b-1d65584d6bb1	14
314111	mirtazapine 30 MG Oral Tablet	PSN	82a615a0-e74a-49cb-9a57-ffbb3df604d5	14
314111	mirtazapine 30 MG Oral Tablet	PSN	aa05d606-29fd-443e-802b-1d65584d6bb1	14
311726	mirtazapine 45 MG Oral Tablet	PSN	82a615a0-e74a-49cb-9a57-ffbb3df604d5	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
311725	mirtazapine 15 MG Oral Tablet	SCD	82a615a0-e74a-49cb-9a57-ffbb3df604d5	14
314111	mirtazapine 30 MG Oral Tablet	SCD	82a615a0-e74a-49cb-9a57-ffbb3df604d5	14
314111	mirtazapine 30 MG Oral Tablet	SCD	aa05d606-29fd-443e-802b-1d65584d6bb1	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	f54718d1-3ef7-4472-9e97-90e5fd30db4d	12
311725	mirtazapine 15 MG Oral Tablet	SCD	f54718d1-3ef7-4472-9e97-90e5fd30db4d	12
311725	mirtazapine 15 MG Oral Tablet	PSN	81d9e47e-ae81-4755-a5ee-546a038fadb4	11
311725	mirtazapine 15 MG Oral Tablet	SCD	81d9e47e-ae81-4755-a5ee-546a038fadb4	11
311725	mirtazapine 15 MG Oral Tablet	PSN	beaa0678-e4b9-4241-8b08-e69e2e49530f	9
311725	mirtazapine 15 MG Oral Tablet	SCD	beaa0678-e4b9-4241-8b08-e69e2e49530f	9
311725	mirtazapine 15 MG Oral Tablet	PSN	758b63b4-904c-4fba-acfc-4d85e3a74c88	5
311725	mirtazapine 15 MG Oral Tablet	SCD	758b63b4-904c-4fba-acfc-4d85e3a74c88	5
311725	mirtazapine 15 MG Oral Tablet	PSN	75dd7e5b-32ec-433b-8379-11cfb372f0d0	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	75dd7e5b-32ec-433b-8379-11cfb372f0d0	3
311726	mirtazapine 45 MG Oral Tablet	SCD	75dd7e5b-32ec-433b-8379-11cfb372f0d0	3
311725	mirtazapine 15 MG Oral Tablet	PSN	f8c383c1-d1b3-ceaa-e053-6294a90a6053	2
311725	mirtazapine 15 MG Oral Tablet	PSN	1d6161e3-2e4e-5446-e054-00144ff8d46c	2
311725	mirtazapine 15 MG Oral Tablet	SCD	1d6161e3-2e4e-5446-e054-00144ff8d46c	2
311725	mirtazapine 15 MG Oral Tablet	SCD	f8c383c1-d1b3-ceaa-e053-6294a90a6053	2
311725	mirtazapine 15 MG Oral Tablet	PSN	20b2b378-f493-4f57-a5c1-54865d8c0183	1
311725	mirtazapine 15 MG Oral Tablet	PSN	20a724c6-feba-40e7-a35a-8a37de2e0136	1
311725	mirtazapine 15 MG Oral Tablet	PSN	1473011e-7c96-482a-83e8-af339cb0b274	1
314111	mirtazapine 30 MG Oral Tablet	PSN	20a724c6-feba-40e7-a35a-8a37de2e0136	1
311725	mirtazapine 15 MG Oral Tablet	SCD	20b2b378-f493-4f57-a5c1-54865d8c0183	1
311725	mirtazapine 15 MG Oral Tablet	SCD	20a724c6-feba-40e7-a35a-8a37de2e0136	1
311725	mirtazapine 15 MG Oral Tablet	SCD	1473011e-7c96-482a-83e8-af339cb0b274	1
314111	mirtazapine 30 MG Oral Tablet	SCD	20a724c6-feba-40e7-a35a-8a37de2e0136	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13107-031-01	13107003101	100 TABLET, FILM COATED in 1 BOTTLE (13107-031-01)	2009-08-17	0000-00-00	No	No	Current
13107-031-05	13107003105	500 TABLET, FILM COATED in 1 BOTTLE (13107-031-05)	2009-08-17	0000-00-00	No	No	Current
13107-031-30	13107003130	30 TABLET, FILM COATED in 1 BOTTLE (13107-031-30)	2009-08-17	0000-00-00	No	No	Current
13107-031-32	13107003132	30 TABLET, FILM COATED in 1 BLISTER PACK (13107-031-32)	2009-08-17	0000-00-00	No	No	Current
13107-031-34	13107003134	30 TABLET, FILM COATED in 1 BOTTLE (13107-031-34)	2009-08-17	0000-00-00	No	No	Current
13107-031-60	13107003160	60 TABLET, FILM COATED in 1 BOTTLE (13107-031-60)	2009-08-17	0000-00-00	No	No	Current
13107-031-90	13107003190	90 TABLET, FILM COATED in 1 BOTTLE (13107-031-90)	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	Unit Dose Solutions, Inc.	2026-06-27	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine	REMEDYREPACK INC.	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	12
Mirtazapine	REMEDYREPACK INC.	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	11
Mirtazapine	A-S Medication Solutions	2026-01-14	Human Prescription Drug Label	21
Mirtazapine	Bryant Ranch Prepack	2025-11-18	HUMAN PRESCRIPTION DRUG LABEL	9
Mirtazapine	Aurolife Pharma LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-09-10	Human Prescription Drug Label	14
Mirtazapine HCL Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	Quality Care Products LLC	2024-12-16	Human Prescription Drug Label	10
Mirtazapine	Preferred Pharmaceuticals, Inc.	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	5
Mirtazapine	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	5
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	NuCare Pharmaceuticals,Inc.	2021-02-19	HUMAN PRESCRIPTION DRUG LABEL	2
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	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	Medsource Pharmaceuticals	2019-11-10	HUMAN PRESCRIPTION DRUG LABEL	2
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	Aidarex Pharmaceuticals LLC	2014-01-14	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	State of Florida DOH Central Pharmacy	2013-09-25	HUMAN PRESCRIPTION DRUG LABEL	1