Mirtazapine

Product NDC: 60505-0248
11-digit product format: 605050248
Labeler code: 60505
Product ID: 60505-0248_c076cd92-b06d-b317-cc04-6f99b3718cf7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA077666
Marketing category: ANDA
Marketing start: 2007-08-22
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
60505-0248-1	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	20
60505-0248-3	Mirtazapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	20
60505-0248-5	Mirtazapine	500 in 1 BOTTLE	TABLET, FILM COATED	500	20
60505-0248-8	Mirtazapine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0248-1	EA - Each	60505-0248	4bd9f008-a937-4d1f-84b2-e22441f288c7	1	2013-02-13
60505-0248-8	EA - Each	60505-0248	ed82d228-2b0d-40ef-9481-6baa52c287fb	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	3
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
HYPROMELLOSE 2910 (6 CPS)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	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
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	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
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	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
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	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
60505-0248	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	19	Current NDC, Legacy NDC, 4 package rows	20241105_9675333e-3064-c8cb-a4b4-6c74d9a82f17.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	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
314111	mirtazapine 30 MG Oral Tablet	PSN	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
311726	mirtazapine 45 MG Oral Tablet	PSN	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
311725	mirtazapine 15 MG Oral Tablet	SCD	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
314111	mirtazapine 30 MG Oral Tablet	SCD	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
311726	mirtazapine 45 MG Oral Tablet	SCD	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
311725	mirtazapine 15 MG Oral Tablet	PSN	40c95daa-bbd5-48d9-97e4-c87f2c1f0fa5	11
314111	mirtazapine 30 MG Oral Tablet	PSN	40c95daa-bbd5-48d9-97e4-c87f2c1f0fa5	11
311725	mirtazapine 15 MG Oral Tablet	SCD	40c95daa-bbd5-48d9-97e4-c87f2c1f0fa5	11
314111	mirtazapine 30 MG Oral Tablet	SCD	40c95daa-bbd5-48d9-97e4-c87f2c1f0fa5	11
311725	mirtazapine 15 MG Oral Tablet	PSN	44779383-3ddb-41df-8766-da5d7bef385e	9
314111	mirtazapine 30 MG Oral Tablet	PSN	44779383-3ddb-41df-8766-da5d7bef385e	9
311725	mirtazapine 15 MG Oral Tablet	SCD	44779383-3ddb-41df-8766-da5d7bef385e	9
314111	mirtazapine 30 MG Oral Tablet	SCD	44779383-3ddb-41df-8766-da5d7bef385e	9
314111	mirtazapine 30 MG Oral Tablet	PSN	c4b9346d-534e-4987-bdac-7b06bda05cba	5
314111	mirtazapine 30 MG Oral Tablet	SCD	c4b9346d-534e-4987-bdac-7b06bda05cba	5
314111	mirtazapine 30 MG Oral Tablet	PSN	a2f01ffd-fd48-499b-9126-8eb9048a5722	3
314111	mirtazapine 30 MG Oral Tablet	PSN	ac976282-fb68-4db0-912a-28f075b0716c	3
314111	mirtazapine 30 MG Oral Tablet	SCD	a2f01ffd-fd48-499b-9126-8eb9048a5722	3
314111	mirtazapine 30 MG Oral Tablet	SCD	ac976282-fb68-4db0-912a-28f075b0716c	3
311725	mirtazapine 15 MG Oral Tablet	PSN	34c0b734-98ca-4aec-965f-e55edd3317f3	2
314111	mirtazapine 30 MG Oral Tablet	PSN	34c0b734-98ca-4aec-965f-e55edd3317f3	2
311726	mirtazapine 45 MG Oral Tablet	PSN	34c0b734-98ca-4aec-965f-e55edd3317f3	2
311725	mirtazapine 15 MG Oral Tablet	SCD	34c0b734-98ca-4aec-965f-e55edd3317f3	2
314111	mirtazapine 30 MG Oral Tablet	SCD	34c0b734-98ca-4aec-965f-e55edd3317f3	2
311726	mirtazapine 45 MG Oral Tablet	SCD	34c0b734-98ca-4aec-965f-e55edd3317f3	2
314111	mirtazapine 30 MG Oral Tablet	PSN	715e69c6-f113-fd17-e053-2995a90a6c81	1
314111	mirtazapine 30 MG Oral Tablet	PSN	35922615-7619-3852-e063-6394a90a2e55	1
314111	mirtazapine 30 MG Oral Tablet	SCD	715e69c6-f113-fd17-e053-2995a90a6c81	1
314111	mirtazapine 30 MG Oral Tablet	SCD	35922615-7619-3852-e063-6394a90a2e55	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0248-1	60505024801	30 TABLET, FILM COATED in 1 BOTTLE (60505-0248-1)	2007-08-22	0000-00-00	No	No	Current
60505-0248-3	60505024803	100 TABLET, FILM COATED in 1 BOTTLE (60505-0248-3)	2007-08-22	0000-00-00	No	No	Current
60505-0248-5	60505024805	500 TABLET, FILM COATED in 1 BOTTLE (60505-0248-5)	2007-08-22	0000-00-00	No	No	Current
60505-0248-8	60505024808	1000 TABLET, FILM COATED in 1 BOTTLE (60505-0248-8)	2007-08-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	A-S Medication Solutions	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	9
Mirtazapine	Apotex Corp. \| Apotex Inc	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	20
Mirtazapine	AvKARE	2025-05-20	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2025-01-14	HUMAN PRESCRIPTION DRUG LABEL	11
MIRTAZAPINE TABLETS, USP 15 mg, 30 mg and 45 mg Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2024-06-28	HUMAN PRESCRIPTION DRUG LABEL	3
MIRTAZAPINE	DIRECT RX	2023-04-12	HUMAN PRESCRIPTION DRUG LABEL	5
Mirtazapine Tablets, USP 15 mg, 30 mg and 45 mg Rx Only	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	3
MIRTAZAPINE TABLETS, USP Rx Only	Medsource Pharmaceuitcals \| Medsource Pharmaceuticals	2018-07-19	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine Tablets, USP	State of Florida DOH Central Pharmacy	2010-08-06	HUMAN PRESCRIPTION DRUG LABEL	2

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#