Mirtazapine

Product NDC: 13107-001
11-digit product format: 131070001
Labeler code: 13107
Product ID: 13107-001_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: 7.5 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	7.5 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
13107-001-01	Mirtazapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	14
13107-001-05	Mirtazapine	500 in 1 BOTTLE	TABLET, FILM COATED	500	14
13107-001-30	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
13107-001-60	Mirtazapine	60 in 1 BOTTLE	TABLET, FILM COATED	60	14
13107-001-90	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
13107-001-05	EA - Each	13107-001	45a32c21-e565-4a76-ad48-ad95d1fa7ae0	1	2014-01-04
13107-001-30	EA - Each	13107-001	aa8a9001-6846-43f8-b9bd-6255f988db9d	1	2014-01-04

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 [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
HYDROXYPROPYL CELLULOSE (TYPE L)	INACTIVE INGREDIENT	UKE75GEA7F	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-001	MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	13	Current NDC, Legacy NDC, 5 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
476809	mirtazapine 7.5 MG Oral Tablet	PSN	bd532a25-cfde-4c7d-8015-ba40609fb95c	103
476809	mirtazapine 7.5 MG Oral Tablet	SCD	bd532a25-cfde-4c7d-8015-ba40609fb95c	103
476809	mirtazapine 7.5 MG Oral Tablet	PSN	c2b38cc5-7738-44fa-9bef-89a18a1039b2	100
476809	mirtazapine 7.5 MG Oral Tablet	PSN	55c5905c-6cb8-4ed4-8e69-97f733ca91b5	100
476809	mirtazapine 7.5 MG Oral Tablet	SCD	c2b38cc5-7738-44fa-9bef-89a18a1039b2	100
476809	mirtazapine 7.5 MG Oral Tablet	SCD	55c5905c-6cb8-4ed4-8e69-97f733ca91b5	100
311725	mirtazapine 15 MG Oral Tablet	PSN	aa05d606-29fd-443e-802b-1d65584d6bb1	14
314111	mirtazapine 30 MG Oral Tablet	PSN	aa05d606-29fd-443e-802b-1d65584d6bb1	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
314111	mirtazapine 30 MG Oral Tablet	SCD	aa05d606-29fd-443e-802b-1d65584d6bb1	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
476809	mirtazapine 7.5 MG Oral Tablet	PSN	3b7a5f44-8da6-4196-bb5d-8d2770af1b3a	5
476809	mirtazapine 7.5 MG Oral Tablet	SCD	3b7a5f44-8da6-4196-bb5d-8d2770af1b3a	5
476809	mirtazapine 7.5 MG Oral Tablet	PSN	e6e5cbf7-a958-4ef8-abcc-a7491edb9520	4
476809	mirtazapine 7.5 MG Oral Tablet	SCD	e6e5cbf7-a958-4ef8-abcc-a7491edb9520	4
476809	mirtazapine 7.5 MG Oral Tablet	PSN	2990e296-2d66-70c0-e063-6394a90abbe4	1
476809	mirtazapine 7.5 MG Oral Tablet	SCD	2990e296-2d66-70c0-e063-6394a90abbe4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13107-001-01	13107000101	100 TABLET, FILM COATED in 1 BOTTLE (13107-001-01)	2009-08-17	0000-00-00	No	No	Current
13107-001-05	13107000105	500 TABLET, FILM COATED in 1 BOTTLE (13107-001-05)	2009-08-17	0000-00-00	No	No	Current
13107-001-30	13107000130	30 TABLET, FILM COATED in 1 BOTTLE (13107-001-30)	2009-08-17	0000-00-00	No	No	Current
13107-001-60	13107000160	60 TABLET, FILM COATED in 1 BOTTLE (13107-001-60)	2009-08-17	0000-00-00	No	No	Current
13107-001-90	13107000190	90 TABLET, FILM COATED in 1 BOTTLE (13107-001-90)	2009-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	Bryant Ranch Prepack	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	100
Mirtazapine	Bryant Ranch Prepack	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	103
Mirtazapine	Bryant Ranch Prepack	2025-11-04	HUMAN PRESCRIPTION DRUG LABEL	100
Mirtazapine	Aurolife Pharma LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-09-10	Human Prescription Drug Label	14
Mirtazapine	REMEDYREPACK INC.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	9
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	ATLANTIC BIOLOGICALS CORP. \| ATLANTIC BIOOGICALS CORP.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	4
Mirtazapine	American Health Packaging	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	5
Mirtazapine	Coupler LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only	NCS HealthCare of KY, Inc dba Vangard Labs	2015-01-15	HUMAN PRESCRIPTION DRUG LABEL	3