Mirtazapine

Product NDC: 0378-3530
11-digit product format: 003783530
Labeler code: 0378
Product ID: 0378-3530_681d9ec4-046b-4c0e-b85f-2468620c724b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA076122
Marketing category: ANDA
Marketing start: 2003-06-20
Substance: MIRTAZAPINE
Active strength: 30 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 Identifiers#

Field, Values table
Field	Values
Unii	A051Q2099Q
Rxcui	311725, 311726, 314111

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
0378-3530-01	Mirtazapine	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	20
0378-3530-05	Mirtazapine	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	20
0378-3530-70	Mirtazapine	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	20
0378-3530-93	Mirtazapine	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3530-01	EA - Each	0378-3530	a2a7d783-92cc-4e4e-b38e-dff51b52a06f	1	2016-06-14
0378-3530-05	EA - Each	0378-3530	e6eae824-4bb7-4dfc-86c2-41b49abaf793	1	2012-07-24
0378-3530-70	EA - Each	0378-3530	7cb6f77f-f69c-493f-b688-cfc5c5a032ae	1	2016-03-04
0378-3530-93	EA - Each	0378-3530	d2aa8a1f-22fd-4c30-b3f4-eccdec17ba1f	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 [MYLAN PHARMACEUTICALS INC.]	7
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
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
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-3530	MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	20	Current NDC, Legacy NDC, 4 package rows	20221019_711aa80b-8fc6-49e6-9494-3db31d9b53a4.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	711aa80b-8fc6-49e6-9494-3db31d9b53a4	20
314111	mirtazapine 30 MG Oral Tablet	PSN	711aa80b-8fc6-49e6-9494-3db31d9b53a4	20
311726	mirtazapine 45 MG Oral Tablet	PSN	711aa80b-8fc6-49e6-9494-3db31d9b53a4	20
311725	mirtazapine 15 MG Oral Tablet	SCD	711aa80b-8fc6-49e6-9494-3db31d9b53a4	20
314111	mirtazapine 30 MG Oral Tablet	SCD	711aa80b-8fc6-49e6-9494-3db31d9b53a4	20
311726	mirtazapine 45 MG Oral Tablet	SCD	711aa80b-8fc6-49e6-9494-3db31d9b53a4	20
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	a6a5949f-5ebf-f37d-e053-2995a90adae5	5
314111	mirtazapine 30 MG Oral Tablet	PSN	a6a5949f-5ebf-f37d-e053-2995a90adae5	5
311726	mirtazapine 45 MG Oral Tablet	PSN	a6a5949f-5ebf-f37d-e053-2995a90adae5	5
311725	mirtazapine 15 MG Oral Tablet	SCD	a6a5949f-5ebf-f37d-e053-2995a90adae5	5
314111	mirtazapine 30 MG Oral Tablet	SCD	a6a5949f-5ebf-f37d-e053-2995a90adae5	5
311726	mirtazapine 45 MG Oral Tablet	SCD	a6a5949f-5ebf-f37d-e053-2995a90adae5	5
311725	mirtazapine 15 MG Oral Tablet	PSN	6d2ff278-0c80-4373-b77d-b5f186c4b991	3
314111	mirtazapine 30 MG Oral Tablet	PSN	6d2ff278-0c80-4373-b77d-b5f186c4b991	3
311726	mirtazapine 45 MG Oral Tablet	PSN	6d2ff278-0c80-4373-b77d-b5f186c4b991	3
311725	mirtazapine 15 MG Oral Tablet	SCD	6d2ff278-0c80-4373-b77d-b5f186c4b991	3
314111	mirtazapine 30 MG Oral Tablet	SCD	6d2ff278-0c80-4373-b77d-b5f186c4b991	3
311726	mirtazapine 45 MG Oral Tablet	SCD	6d2ff278-0c80-4373-b77d-b5f186c4b991	3
311725	mirtazapine 15 MG Oral Tablet	PSN	03395e21-ea63-4a4b-b1e0-418c414a35fc	2
314111	mirtazapine 30 MG Oral Tablet	PSN	03395e21-ea63-4a4b-b1e0-418c414a35fc	2
311725	mirtazapine 15 MG Oral Tablet	SCD	03395e21-ea63-4a4b-b1e0-418c414a35fc	2
314111	mirtazapine 30 MG Oral Tablet	SCD	03395e21-ea63-4a4b-b1e0-418c414a35fc	2
311725	mirtazapine 15 MG Oral Tablet	PSN	310d8699-2c46-44e8-8c5f-79f01517a4a6	1
311725	mirtazapine 15 MG Oral Tablet	PSN	912e850f-a0bf-4e07-a800-43479eeffb05	1
314111	mirtazapine 30 MG Oral Tablet	PSN	912e850f-a0bf-4e07-a800-43479eeffb05	1
314111	mirtazapine 30 MG Oral Tablet	PSN	310d8699-2c46-44e8-8c5f-79f01517a4a6	1
311726	mirtazapine 45 MG Oral Tablet	PSN	912e850f-a0bf-4e07-a800-43479eeffb05	1
311726	mirtazapine 45 MG Oral Tablet	PSN	310d8699-2c46-44e8-8c5f-79f01517a4a6	1
311725	mirtazapine 15 MG Oral Tablet	SCD	310d8699-2c46-44e8-8c5f-79f01517a4a6	1
311725	mirtazapine 15 MG Oral Tablet	SCD	912e850f-a0bf-4e07-a800-43479eeffb05	1
314111	mirtazapine 30 MG Oral Tablet	SCD	912e850f-a0bf-4e07-a800-43479eeffb05	1
314111	mirtazapine 30 MG Oral Tablet	SCD	310d8699-2c46-44e8-8c5f-79f01517a4a6	1
311726	mirtazapine 45 MG Oral Tablet	SCD	310d8699-2c46-44e8-8c5f-79f01517a4a6	1
311726	mirtazapine 45 MG Oral Tablet	SCD	912e850f-a0bf-4e07-a800-43479eeffb05	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-3530-01	00378353001	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3530-01)	2016-08-02	0000-00-00	No	No	Current
0378-3530-05	00378353005	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3530-05)	2003-06-20	0000-00-00	No	No	Current
0378-3530-70	00378353070	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3530-70)	2003-06-20	2021-12-31	No	No	Current
0378-3530-93	00378353093	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3530-93)	2003-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	Safecor Health LLC	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	3
Mirtazapine	Mylan Institutional Inc.	2025-07-22	HUMAN PRESCRIPTION DRUG LABEL	16
Mirtazapine	Golden State Medical Supply, Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	5
Mirtazapine	Mylan Pharmaceuticals Inc.	2022-10-04	HUMAN PRESCRIPTION DRUG LABEL	20
Mirtazapine - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2016-06-21	HUMAN PRESCRIPTION DRUG LABEL	2
Mirtazapine - Contract Pharmacy Services-PA	Contract Pharmacy Services-PA	2010-06-30	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine	Physicians Total Care, Inc.	2010-05-25	HUMAN PRESCRIPTION DRUG LABEL	1

Mirtazapine

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#