Mirtazapine

Product NDC: 57237-011
Requested package NDC: 57237-011-06
11-digit product format: 572370011
Labeler code: 57237
Product ID: 57237-011_ed2cd1df-697f-4e63-8097-7802be5eb6bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA077376
Marketing category: ANDA
Marketing start: 2005-12-08
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077376-002	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08
A077376-003	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08
A077376-004	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077376-002	AB
A077376-003	AB
A077376-004	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.

Product history page 1 of 4 · 123 observed 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
2026-02-19 14:30 UTC	2026-02	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077376-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077376-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077376-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077376-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077376-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077376-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077376-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077376-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077376-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077376-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077376-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077376-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077376-002	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283406	Internal RxNorm lookup
283407	Internal RxNorm lookup
283485	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
73b7bbd9-7dba-4559-890f-3f8dd821e215	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	Strength	SPL version
57237-011-06	Mirtazapine	5 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	5		14
57237-011-06	Mirtazapine	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-011-06	EA - Each	57237-011	c6fc0d34-737d-485a-b49f-543622e8db43	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	2
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-011	MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [RISING PHARMA HOLDINGS, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20240201_73b7bbd9-7dba-4559-890f-3f8dd821e215.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	f86f1175-806f-4416-af86-b1e28def8244	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077376 application number: ANDA077376
Mirtazapine	MIRTAZAPINE	Rising Pharma Holdings, Inc.	73b7bbd9-7dba-4559-890f-3f8dd821e215	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077376 application number: ANDA077376 ndc (package): 57237-011-06 ndc (product): 57237-011 ndc11 (package): 57237001106
Mirtazapine	MIRTAZAPINE	Cardinal Health 107, LLC	5127517f-b8d0-4af1-8a2f-5225719600bc	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077376 application number: ANDA077376
Mirtazapine	MIRTAZAPINE	Aurobindo Pharma Limited	3a8a4490-9243-4201-944d-cea27d3d69f5	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077376 application number: ANDA077376

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
283406	mirtazapine 15 MG Disintegrating Oral Tablet	PSN	73b7bbd9-7dba-4559-890f-3f8dd821e215	14
283407	mirtazapine 30 MG Disintegrating Oral Tablet	PSN	73b7bbd9-7dba-4559-890f-3f8dd821e215	14
283485	mirtazapine 45 MG Disintegrating Oral Tablet	PSN	73b7bbd9-7dba-4559-890f-3f8dd821e215	14
283406	mirtazapine 15 MG Disintegrating Oral Tablet	SCD	73b7bbd9-7dba-4559-890f-3f8dd821e215	14
283407	mirtazapine 30 MG Disintegrating Oral Tablet	SCD	73b7bbd9-7dba-4559-890f-3f8dd821e215	14
283485	mirtazapine 45 MG Disintegrating Oral Tablet	SCD	73b7bbd9-7dba-4559-890f-3f8dd821e215	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-011-06	57237001106	5 BLISTER PACK in 1 CARTON (57237-011-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	5 blister pack	2005-12-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2025-09-11	Human Prescription Drug Label	14
Mirtazapine	Bryant Ranch Prepack	2021-12-27	HUMAN PRESCRIPTION DRUG LABEL	4