Mirtazapine

Product NDC: 42291-952
11-digit product format: 422910952
Labeler code: 42291
Product ID: 42291-952_35923954-c6ec-3d84-e063-6394a90aecf4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA077666
Marketing category: ANDA
Marketing start: 2025-05-20
Substance: MIRTAZAPINE
Active strength: 30 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 42.

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
A077666-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22
A077666-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22
A077666-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077666-001	AB
A077666-002	AB
A077666-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077666-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077666-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077666-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077666-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077666-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077666-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077666-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077666-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077666-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077666-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077666-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077666-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077666-001	AB	1	`1e350fbaab3a…`

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 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314111	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
35922615-7619-3852-e063-6394a90a2e55	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
42291-952-50	Mirtazapine	500 in 1 BOTTLE	TABLET, FILM COATED	500		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-952-50	EA - Each	42291-952	51f8c249-ee54-4ce7-a149-ffd1f41f84b5	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-952	MIRTAZAPINE TABLET, FILM COATED [AVKARE]	1	Current NDC, 1 package rows	20250522_35922615-7619-3852-e063-6394a90a2e55.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	A-S Medication Solutions	44779383-3ddb-41df-8766-da5d7bef385e	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Direct_Rx	dea8c09a-b759-1da7-e053-2a95a90a3346	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Cardinal Health 107, LLC	df06ea51-a962-49d0-a449-137e2220ce7e	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Apotex Corp.	9675333e-3064-c8cb-a4b4-6c74d9a82f17	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Coupler LLC	3eed8213-a240-fc4b-e063-6294a90a3b05	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Major Pharmaceuticals	a80463be-f2d2-4074-9bd8-5e52b0832b3a	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	AvKARE	35922615-7619-3852-e063-6394a90a2e55	2025-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666 ndc (product): 42291-952
Mirtazapine	MIRTAZAPINE	McKesson Corporation dba SKY Packaging	40c95daa-bbd5-48d9-97e4-c87f2c1f0fa5	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	ac976282-fb68-4db0-912a-28f075b0716c	2024-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	faba9bfd-6725-4917-ab48-24e58b397eb4	2023-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Proficient Rx LP	3b516a33-b164-4e4f-bc18-e9d1e591323a	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Proficient Rx LP	a2f01ffd-fd48-499b-9126-8eb9048a5722	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666

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
314111	mirtazapine 30 MG Oral Tablet	PSN	35922615-7619-3852-e063-6394a90a2e55	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	Sample	Exclude flag	Status
42291-952-50	42291095250	500 TABLET, FILM COATED in 1 BOTTLE (42291-952-50)	2025-05-20	No	No	Current