Mirtazapine

Product NDC: 42291-494
Requested package NDC: 42291-494-90
11-digit product format: 422910494
Labeler code: 42291
Product ID: 42291-494_3f7cebc7-2ea8-12e2-e063-6394a90abdc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA076541
Marketing category: ANDA
Marketing start: 2022-08-02
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	RLD / RS	Approval date
A076541-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22
A076541-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22
A076541-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22
A076541-004	MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076541-001	AB
A076541-002	AB
A076541-003	AB
A076541-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076541-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB		2004-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076541-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB		2004-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076541-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB		2004-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076541-004	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	RS	2004-04-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A076541-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076541-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076541-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076541-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076541-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076541-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076541-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076541-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076541-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076541-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076541-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076541-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076541-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076541-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076541-004	AB	1	`d06236e962d9…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
e5478a6a-a29a-9f61-e053-2995a90a11d0	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
42291-494-30	Mirtazapine	30 in 1 BOTTLE	TABLET	30		3
42291-494-90	Mirtazapine	90 in 1 BOTTLE	TABLET	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-494-30	EA - Each	42291-494	524768c7-f182-435a-ba76-3c2f7ae3251a	1	2022-09-12
42291-494-90	EA - Each	42291-494	328e78f6-d02b-4fce-bb34-e64a87be3897	1	2025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-494	MIRTAZAPINE TABLET [AVKARE]	2	Current NDC, Legacy NDC, 2 package rows	20240110_e5478a6a-a29a-9f61-e053-2995a90a11d0.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	Bryant Ranch Prepack	577c3ceb-316b-4c93-9b0c-0a4b1b4773e9	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	e708e8bb-9b13-44d9-96f5-fd73a893a987	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	356eb045-6347-49cc-818e-65b1cdff8f4e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	AvKARE	e5478a6a-a29a-9f61-e053-2995a90a11d0	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541 ndc (package): 42291-494-90 ndc (product): 42291-494 ndc11 (package): 42291049490
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	3bb242b0-42ed-471a-b3c4-5ded1e292e80	2024-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	8c03eb2b-6aed-40a1-a424-67ac1ab6085d	2024-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	ecf7826c-c583-4836-9b00-bf9e4b51a144	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	ded5b83b-f11a-4a6a-bf77-c5fe6dc4c4f5	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	9f0f52e8-3318-4da2-b0d9-ea3d33bfe41e	2023-10-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	1ba111d1-cf92-4cd9-afcb-3bebd1bacd46	2023-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	50ccc34a-4b89-4b07-b153-6c71c6924db1	2023-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541
Mirtazapine	MIRTAZAPINE	Sun Pharmaceutical Industries, Inc.	f23631be-c7ae-46e9-b771-a70be17bc9f0	2021-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076541 application number: ANDA076541

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	e5478a6a-a29a-9f61-e053-2995a90a11d0	3
476809	mirtazapine 7.5 MG Oral Tablet	SCD	e5478a6a-a29a-9f61-e053-2995a90a11d0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-494-90	42291049490	90 TABLET in 1 BOTTLE (42291-494-90)	90 tablet	2025-09-23	No	No	Current