Mirtazapine

Product NDC: 57237-008
11-digit product format: 572370008
Labeler code: 57237
Product ID: 57237-008_7616f3f3-c42e-474d-b201-0235120cff36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA076921
Marketing category: ANDA
Marketing start: 2004-10-22
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 43.

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.

Product history page 1 of 5 · 172 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
2026-09-14 22:38:34	2026-08	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076921-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076921-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076921-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076921-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076921-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 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
58e9b4c6-531f-49c4-a640-6953e70892fe	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
57237-008-05	Mirtazapine	500 in 1 BOTTLE	TABLET, FILM COATED	500		15
57237-008-30	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-008-05	EA - Each	57237-008	434f479b-cb79-40bb-8db9-b4c0b3be476d	1	2014-04-03
57237-008-30	EA - Each	57237-008	02a7cad5-2532-4059-8a11-ede65a010241	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-008	MIRTAZAPINE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20240203_58e9b4c6-531f-49c4-a640-6953e70892fe.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 2 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	REMEDYREPACK INC.	d1b59d87-8442-4c15-8bb9-e39b198d8677	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	c2b38cc5-7738-44fa-9bef-89a18a1039b2	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	1cc1a159-11ec-4040-817b-d57fa827a773	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	1fb26f9b-b075-471d-8cc3-fa39246ec2e4	2025-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	beaa0678-e4b9-4241-8b08-e69e2e49530f	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	bd532a25-cfde-4c7d-8015-ba40609fb95c	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	d0cda063-00c5-0921-ee39-d4de1381f91a	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	55c5905c-6cb8-4ed4-8e69-97f733ca91b5	2025-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Rising Pharma Holdings, Inc.	58e9b4c6-531f-49c4-a640-6953e70892fe	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921 ndc (product): 57237-008
Mirtazapine	MIRTAZAPINE	Aurolife Pharma LLC	aa05d606-29fd-443e-802b-1d65584d6bb1	2025-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Aurobindo Pharma Limited	a4c012f0-50b6-42fb-9f06-a14632f23f2e	2025-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	ATLANTIC BIOLOGICALS CORP.	e6e5cbf7-a958-4ef8-abcc-a7491edb9520	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Direct_Rx	3699b988-6d9a-dcc1-e063-6394a90ab38d	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	NorthStar Rx LLC	979eec8b-1bf4-466b-812e-85a111ce1cb5	2025-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	American Health Packaging	3b7a5f44-8da6-4196-bb5d-8d2770af1b3a	2025-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Advanced Rx Pharmacy of Tennessee, LLC	f8c383c1-d1b3-ceaa-e053-6294a90a6053	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	NuCare Pharmaceuticals,Inc.	8e839bb2-2f67-f224-e053-2a95a90ae5d8	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	NCS HealthCare of KY, LLC dba Vangard Labs	70439462-b632-4d21-8067-560162db3137	2023-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921

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
311725	mirtazapine 15 MG Oral Tablet	PSN	1cc1a159-11ec-4040-817b-d57fa827a773	103
311725	mirtazapine 15 MG Oral Tablet	SCD	1cc1a159-11ec-4040-817b-d57fa827a773	103
311725	mirtazapine 15 MG Oral Tablet	PSN	552e2261-53db-4a27-b277-f7b62c3ea2ed	27
314111	mirtazapine 30 MG Oral Tablet	PSN	552e2261-53db-4a27-b277-f7b62c3ea2ed	27
311725	mirtazapine 15 MG Oral Tablet	SCD	552e2261-53db-4a27-b277-f7b62c3ea2ed	27
314111	mirtazapine 30 MG Oral Tablet	SCD	552e2261-53db-4a27-b277-f7b62c3ea2ed	27
311725	mirtazapine 15 MG Oral Tablet	PSN	9135e7db-cba4-4150-a69c-fdf2a347a785	17
311725	mirtazapine 15 MG Oral Tablet	SCD	9135e7db-cba4-4150-a69c-fdf2a347a785	17
311725	mirtazapine 15 MG Oral Tablet	PSN	d1b59d87-8442-4c15-8bb9-e39b198d8677	15
311725	mirtazapine 15 MG Oral Tablet	PSN	58e9b4c6-531f-49c4-a640-6953e70892fe	15
314111	mirtazapine 30 MG Oral Tablet	PSN	58e9b4c6-531f-49c4-a640-6953e70892fe	15
311726	mirtazapine 45 MG Oral Tablet	PSN	58e9b4c6-531f-49c4-a640-6953e70892fe	15
476809	mirtazapine 7.5 MG Oral Tablet	PSN	58e9b4c6-531f-49c4-a640-6953e70892fe	15
311725	mirtazapine 15 MG Oral Tablet	SCD	d1b59d87-8442-4c15-8bb9-e39b198d8677	15
311725	mirtazapine 15 MG Oral Tablet	SCD	58e9b4c6-531f-49c4-a640-6953e70892fe	15
314111	mirtazapine 30 MG Oral Tablet	SCD	58e9b4c6-531f-49c4-a640-6953e70892fe	15
311726	mirtazapine 45 MG Oral Tablet	SCD	58e9b4c6-531f-49c4-a640-6953e70892fe	15
476809	mirtazapine 7.5 MG Oral Tablet	SCD	58e9b4c6-531f-49c4-a640-6953e70892fe	15
311725	mirtazapine 15 MG Oral Tablet	PSN	c22c4325-4f1a-4d12-8039-d3b1263fa3ad	9
311725	mirtazapine 15 MG Oral Tablet	SCD	c22c4325-4f1a-4d12-8039-d3b1263fa3ad	9
311725	mirtazapine 15 MG Oral Tablet	PSN	0f19ab40-1a30-4ac2-9bd7-c2f8199e29e1	2
311725	mirtazapine 15 MG Oral Tablet	SCD	0f19ab40-1a30-4ac2-9bd7-c2f8199e29e1	2
311725	mirtazapine 15 MG Oral Tablet	PSN	b274a701-d523-3fe3-e053-2995a90ac7e0	1
311725	mirtazapine 15 MG Oral Tablet	PSN	3bda4994-cdf5-47b4-aebc-7297347334e9	1
311725	mirtazapine 15 MG Oral Tablet	PSN	26aac059-4819-7ad4-e063-6394a90a9766	1
311725	mirtazapine 15 MG Oral Tablet	PSN	e38c96d4-ea33-3f1a-e053-2a95a90a0903	1
311725	mirtazapine 15 MG Oral Tablet	SCD	b274a701-d523-3fe3-e053-2995a90ac7e0	1
311725	mirtazapine 15 MG Oral Tablet	SCD	3bda4994-cdf5-47b4-aebc-7297347334e9	1
311725	mirtazapine 15 MG Oral Tablet	SCD	26aac059-4819-7ad4-e063-6394a90a9766	1
311725	mirtazapine 15 MG Oral Tablet	SCD	e38c96d4-ea33-3f1a-e053-2a95a90a0903	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-008-05	57237000805	500 TABLET, FILM COATED in 1 BOTTLE (57237-008-05)	2004-10-22	0000-00-00	No	No	Current
57237-008-30	57237000830	30 TABLET, FILM COATED in 1 BOTTLE (57237-008-30)	2004-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	NuCare Pharmaceuticals,Inc.	2026-08-26	HUMAN PRESCRIPTION DRUG LABEL	2
Mirtazapine	REMEDYREPACK INC.	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	19
Mirtazapine	Preferred Pharmaceuticals Inc.	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	10
Mirtazapine	A-S Medication Solutions	2026-02-12	Human Prescription Drug Label	27
Mirtazapine	REMEDYREPACK INC.	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	15
Mirtazapine	Bryant Ranch Prepack	2025-11-21	HUMAN PRESCRIPTION DRUG LABEL	103
Mirtazapine	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-09-12	Human Prescription Drug Label	15
Mirtazapine	Quality Care Products, LLC	2024-12-19	Human Prescription Drug Label	3
Mirtazapine	Coupler LLC	2024-11-11	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine	Proficient Rx LP	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	2
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only	NuCare Pharmaceuticals,Inc.	2021-02-18	HUMAN PRESCRIPTION DRUG LABEL	2
Mirtazapine	Medsource Pharmaceuticals	2020-10-24	HUMAN PRESCRIPTION DRUG LABEL	1
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only	Aphena Pharma Solutions - Tennessee, LLC	2018-08-24	Human Prescription Drug Label	1
Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only	NuCare Pharmaceuticals,Inc.	2018-02-20	HUMAN PRESCRIPTION DRUG LABEL	1