Mirtazapine

Product NDC: 13107-032
11-digit product format: 131070032
Labeler code: 13107
Product ID: 13107-032_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: 45 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	45 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	A051Q2099Q
Rxcui	311725, 311726, 314111, 476809

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
13107-032-01	Mirtazapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	14
13107-032-05	Mirtazapine	500 in 1 BOTTLE	TABLET, FILM COATED	500	14
13107-032-32	Mirtazapine	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	14
13107-032-34	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
13107-032-60	Mirtazapine	60 in 1 BOTTLE	TABLET, FILM COATED	60	14
13107-032-90	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
13107-032-05	EA - Each	13107-032	5d8e602a-b341-47dd-9d95-b9c997a28c25	1	2012-07-24
13107-032-30	EA - Each	13107-032	23fa2f4e-4e88-4db5-b7ee-df88b0fbf47f	1	2013-02-11
13107-032-34	EA - Each	13107-032	2eb46fcb-660d-4237-83df-82759e5d0a5b	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 [BRYANT RANCH PREPACK]	2
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	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	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	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 [BRYANT RANCH PREPACK]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	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 [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	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 [BRYANT RANCH PREPACK]	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 [BRYANT RANCH PREPACK]	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 [BRYANT RANCH PREPACK]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-032	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	13	Current NDC, Legacy NDC, 6 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
311726	mirtazapine 45 MG Oral Tablet	PSN	d0cda063-00c5-0921-ee39-d4de1381f91a	15
311726	mirtazapine 45 MG Oral Tablet	SCD	d0cda063-00c5-0921-ee39-d4de1381f91a	15
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	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
314111	mirtazapine 30 MG Oral Tablet	PSN	5aa52c22-f6b8-421c-e053-2991aa0aaf46	1
311726	mirtazapine 45 MG Oral Tablet	PSN	5aa52c22-f6b8-421c-e053-2991aa0aaf46	1
314111	mirtazapine 30 MG Oral Tablet	SCD	5aa52c22-f6b8-421c-e053-2991aa0aaf46	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
13107-032-01	13107003201	100 TABLET, FILM COATED in 1 BOTTLE (13107-032-01)	2009-08-17	0000-00-00	No	No	Current
13107-032-05	13107003205	500 TABLET, FILM COATED in 1 BOTTLE (13107-032-05)	2009-08-17	0000-00-00	No	No	Current
13107-032-32	13107003232	30 TABLET, FILM COATED in 1 BLISTER PACK (13107-032-32)	2009-08-17	0000-00-00	No	No	Current
13107-032-34	13107003234	30 TABLET, FILM COATED in 1 BOTTLE (13107-032-34)	2009-08-17	0000-00-00	No	No	Current
13107-032-60	13107003260	60 TABLET, FILM COATED in 1 BOTTLE (13107-032-60)	2009-08-17	0000-00-00	No	No	Current
13107-032-90	13107003290	90 TABLET, FILM COATED in 1 BOTTLE (13107-032-90)	2009-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	Bryant Ranch Prepack	2025-11-10	HUMAN PRESCRIPTION DRUG LABEL	15
Mirtazapine	Aurolife Pharma LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-09-10	Human Prescription Drug Label	14
Mirtazapine	American Health Packaging	2024-10-02	HUMAN PRESCRIPTION DRUG LABEL	14
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
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

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#