REMERONSOLTAB

Product NDC: 0052-0106
11-digit product format: 000520106
Labeler code: 0052
Product ID: 0052-0106_325197a6-1a5f-4c6f-bb05-c8b3f64ce3ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MIRTAZAPINE
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Organon USA Inc.
Application: NDA021208
Marketing category: NDA
Marketing start: 2001-01-12
Marketing end: 0000-00-00
Substance: MIRTAZAPINE
Active strength: 15 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0052-0106		D	Discontinued by firm		2026-08-03
excluded package	package	0052-0106	0052-0106-30	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0052-0106-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0052-0106-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0052-0106-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0052-0106-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0052-0106-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0052-0106-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0052-0106-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0052-0106-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0052-0106-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0052-0106-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0052-0106-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0052-0106-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	RLD / RS	Approval date
N021208-001	REMERON SOLTAB	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12
N021208-002	REMERON SOLTAB	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12
N021208-003	REMERON SOLTAB	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021208-001	AB
N021208-002	AB
N021208-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`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	N021208-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021208-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021208-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021208-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021208-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021208-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021208-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021208-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021208-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021208-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0052-0106-06	EA - Each	0052-0106	d9887806-9e59-4528-90cc-5c5c9154f786	1	2015-12-02
0052-0106-30	EA - Each	0052-0106	1a88ce9b-9fdf-4715-b6d7-56f4fbb27565	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
SUCROSE	INACTIVE INGREDIENT	C151H8M554	REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON USA INC.]	20
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]	19
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]	19
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]	19
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]	19
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]	19
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]	19
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.]	19

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REMERONSOLTAB	MIRTAZAPINE	Organon LLC	98ad1917-a094-44f5-a28f-a64a8cfcd887	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021208 application number: NDA021208

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A051Q2099Q	MIRTAZAPINE	85650-52-8	MIRTAZAPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0052-0106-30	00052010630	5 BLISTER PACK in 1 BOX (0052-0106-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0052-0106-06)	5 blister pack	2001-01-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
REMERON	Organon USA Inc.	2021-10-08	HUMAN PRESCRIPTION DRUG LABEL	32
ONCE-A-DAY REMERONSolTab ® (mirtazapine) Orally Disintegrating Tablets	Organon USA Inc.	2019-09-05	HUMAN PRESCRIPTION DRUG LABEL	26