Mirtazapine

Product NDC: 72578-103
11-digit product format: 725780103
Labeler code: 72578
Product ID: 72578-103_9ad8f423-a877-4069-8a11-92e1f934974a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Viona Pharmaceuticals Inc.
Application: ANDA205798
Marketing category: ANDA
Marketing start: 2022-08-07
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
A205798-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01
A205798-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01
A205798-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205798-001	AB
A205798-002	AB
A205798-003	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	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`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	A205798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205798-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205798-001	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
ed491abe-9412-428b-8e24-57242862c99a	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
72578-103-69	Mirtazapine	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6		4
72578-103-84	Mirtazapine	5 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	5		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72578-103-69	EA - Each	72578-103	c344ee58-b887-422f-9dbd-2d1c21b3e87e	1	2024-07-12
72578-103-84	EA - Each	72578-103	58e6addf-ff60-42e7-babe-46e961116f9b	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72578-103	MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [VIONA PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 2 package rows	20240711_ed491abe-9412-428b-8e24-57242862c99a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	Viona Pharmaceuticals Inc.	ed491abe-9412-428b-8e24-57242862c99a	2025-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205798 application number: ANDA205798 ndc (product): 72578-103
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	c47428e5-4717-4471-9231-ec8b5438205a	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205798 application number: ANDA205798
Mirtazapine	MIRTAZAPINE	SQUARE PHARMACEUTICALS LIMITED	83093852-d212-408e-98fd-33f4603a9d65	2023-07-02		Exact identifier application applno (ANDA): 205798 application number: ANDA205798

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	ed491abe-9412-428b-8e24-57242862c99a	4
283407	mirtazapine 30 MG Disintegrating Oral Tablet	PSN	ed491abe-9412-428b-8e24-57242862c99a	4
283485	mirtazapine 45 MG Disintegrating Oral Tablet	PSN	ed491abe-9412-428b-8e24-57242862c99a	4
283406	mirtazapine 15 MG Disintegrating Oral Tablet	SCD	ed491abe-9412-428b-8e24-57242862c99a	4
283407	mirtazapine 30 MG Disintegrating Oral Tablet	SCD	ed491abe-9412-428b-8e24-57242862c99a	4
283485	mirtazapine 45 MG Disintegrating Oral Tablet	SCD	ed491abe-9412-428b-8e24-57242862c99a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72578-103-69	72578010369	6 in 1 BLISTER PACK						Historical
72578-103-84	72578010384	5 BLISTER PACK in 1 CARTON (72578-103-84) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-103-69)	5 blister pack	2022-08-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	Viona Pharmaceuticals Inc. \| SQUARE PHARMACEUTICALS PLC.	2025-06-24	HUMAN PRESCRIPTION DRUG LABEL	4