FDA.reportPublic FDA data

REMERONSOLTAB

Product NDC
78206-159
11-digit product format
782060159
Labeler code
78206
Product ID
78206-159_8b121c7c-9bcd-4504-b789-3f551a0fe514
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIRTAZAPINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Organon LLC
Application
NDA021208
Marketing category
NDA
Marketing start
2021-06-01
Substance
MIRTAZAPINE
Active strength
45 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
REMERONSOLTAB
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRTAZAPINE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui211322, 211323, 283406, 283407, 283485, 311725, 314111, 752869, 752870, 752871

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
1ca5a24a-fafa-8fc8-52ac-b403ff18faa5Product name320240216
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
a733d273-402b-1005-9891-1ac1a9c63703Product name220170724
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-159-01REMERONSOLTAB5 in 1 BOXTABLET, ORALLY DISINTEGRATING58
78206-159-99REMERONSOLTAB6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING68

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-159REMERON (MIRTAZAPINE) TABLET, FILM COATED REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON LLC]7Current NDC, Legacy NDC, 2 package rows20250312_98ad1917-a094-44f5-a28f-a64a8cfcd887.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283406mirtazapine 15 MG Disintegrating Oral TabletPSN98ad1917-a094-44f5-a28f-a64a8cfcd8878
311725mirtazapine 15 MG Oral TabletPSN98ad1917-a094-44f5-a28f-a64a8cfcd8878
283407mirtazapine 30 MG Disintegrating Oral TabletPSN98ad1917-a094-44f5-a28f-a64a8cfcd8878
314111mirtazapine 30 MG Oral TabletPSN98ad1917-a094-44f5-a28f-a64a8cfcd8878
283485mirtazapine 45 MG Disintegrating Oral TabletPSN98ad1917-a094-44f5-a28f-a64a8cfcd8878
211322Remeron 15 MG Oral TabletPSN98ad1917-a094-44f5-a28f-a64a8cfcd8878
211323Remeron 30 MG Oral TabletPSN98ad1917-a094-44f5-a28f-a64a8cfcd8878
752869Remeron SolTab 15 MG Disintegrating Oral TabletPSN98ad1917-a094-44f5-a28f-a64a8cfcd8878
752870Remeron SolTab 30 MG Disintegrating Oral TabletPSN98ad1917-a094-44f5-a28f-a64a8cfcd8878
752871Remeron SolTab 45 MG Disintegrating Oral TabletPSN98ad1917-a094-44f5-a28f-a64a8cfcd8878
752869mirtazapine 15 MG Disintegrating Oral Tablet [Remeron]SBD98ad1917-a094-44f5-a28f-a64a8cfcd8878
211322mirtazapine 15 MG Oral Tablet [Remeron]SBD98ad1917-a094-44f5-a28f-a64a8cfcd8878
752870mirtazapine 30 MG Disintegrating Oral Tablet [Remeron]SBD98ad1917-a094-44f5-a28f-a64a8cfcd8878
211323mirtazapine 30 MG Oral Tablet [Remeron]SBD98ad1917-a094-44f5-a28f-a64a8cfcd8878
752871mirtazapine 45 MG Disintegrating Oral Tablet [Remeron]SBD98ad1917-a094-44f5-a28f-a64a8cfcd8878
283406mirtazapine 15 MG Disintegrating Oral TabletSCD98ad1917-a094-44f5-a28f-a64a8cfcd8878
311725mirtazapine 15 MG Oral TabletSCD98ad1917-a094-44f5-a28f-a64a8cfcd8878
283407mirtazapine 30 MG Disintegrating Oral TabletSCD98ad1917-a094-44f5-a28f-a64a8cfcd8878
314111mirtazapine 30 MG Oral TabletSCD98ad1917-a094-44f5-a28f-a64a8cfcd8878
283485mirtazapine 45 MG Disintegrating Oral TabletSCD98ad1917-a094-44f5-a28f-a64a8cfcd8878
752869Remeron 15 MG Disintegrating Oral TabletSY98ad1917-a094-44f5-a28f-a64a8cfcd8878
211322Remeron 15 MG Oral TabletSY98ad1917-a094-44f5-a28f-a64a8cfcd8878
752870Remeron 30 MG Disintegrating Oral TabletSY98ad1917-a094-44f5-a28f-a64a8cfcd8878
211323Remeron 30 MG Oral TabletSY98ad1917-a094-44f5-a28f-a64a8cfcd8878
752871Remeron 45 MG Disintegrating Oral TabletSY98ad1917-a094-44f5-a28f-a64a8cfcd8878

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78206-159-01782060159015 BLISTER PACK in 1 BOX (78206-159-01) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (78206-159-99) 5 blister pack2021-06-010000-00-00NoNoCurrent
78206-159-99782060159996 in 1 BLISTER PACKHistorical