FDA.reportPublic FDA data

mirtazapine 15 MG Oral Tablet

RxCUI
311725
RxNorm name
mirtazapine 15 MG Oral Tablet
Display name
mirtazapine 15 MG Oral Tablet
Full name
mirtazapine 15 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:26

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINEREMEDYREPACK INC.412abf0e-1f96-4d4d-bb56-a23d4699b14c2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINENuCare Pharmaceuticals,Inc.e38c96d4-ea33-3f1a-e053-2a95a90a09032026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINECoupler LLC598e441a-aa1a-6fb3-e063-6394a90a14aa2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINECardinal Health 107, LLC89ae6a33-933f-47aa-a2de-2a71cd3f7d442026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEREMEDYREPACK INC.9135e7db-cba4-4150-a69c-fdf2a347a7852026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEPreferred Pharmaceuticals Inc.c22c4325-4f1a-4d12-8039-d3b1263fa3ad2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINECardinal Health 107, LLC7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEAmerican Health Packaging82a615a0-e74a-49cb-9a57-ffbb3df604d52026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEUnit Dose Solutions, Inc.5539fe37-546b-40a8-e063-6394a90ace1b2026-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEANI Pharmaceuticals, Inc.bb134141-6069-4b86-abac-7783bf5df60d2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINESafecor Health LLC6d2ff278-0c80-4373-b77d-b5f186c4b9912026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEA-S Medication Solutions552e2261-53db-4a27-b277-f7b62c3ea2ed2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEREMEDYREPACK INC.81d9e47e-ae81-4755-a5ee-546a038fadb42026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEA-S Medication Solutions44779383-3ddb-41df-8766-da5d7bef385e2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEDirect_Rxdea8c09a-b759-1da7-e053-2a95a90a33462026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEREMEDYREPACK INC.d1b59d87-8442-4c15-8bb9-e39b198d86772026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEBryant Ranch Prepack1cc1a159-11ec-4040-817b-d57fa827a7732025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINEBryant Ranch Prepackbeaa0678-e4b9-4241-8b08-e69e2e49530f2025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINECardinal Health 107, LLCdf06ea51-a962-49d0-a449-137e2220ce7e2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
MirtazapineMIRTAZAPINECoupler LLC3eed8213-a240-fc4b-e063-6294a90a3b052025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 2 of 2 · 69 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b4b9b66e-87a1-4dbb-9eaf-71221bcb2265mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 199620260403
412abf0e-1f96-4d4d-bb56-a23d4699b14cmirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 199620251002
f8c383c1-d1b3-ceaa-e053-6294a90a6053mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]22Mirtazapine HCL Tablets20241231
20eafce1-50cd-0d9c-e063-6394a90ad6femirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 199620240913
c48701b8-deb4-4863-b20b-1a97c633cd65mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]22MIRTAZAPINE TABLETS, USP 15 mg, 30 mg and 45 mg Rx Only20190328
85f9b2ad-6f45-4625-954b-28a6d6bff517mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]22Revised: August 2014 Mirtazapine Tablets, USP Rx only20140821
424a0710-3ce6-40a1-ada2-c1e4a8578d0fmirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]22Mirtazapine Tablets, USP 15 mg, 30 mg and 45 mg Rx Only20131022
34c0b734-98ca-4aec-965f-e55edd3317f3mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]22Mirtazapine Tablets, USP20100806
3eed8213-a240-fc4b-e063-6294a90a3b05mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. approval: 199620250916
26aac059-4819-7ad4-e063-6394a90a9766mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 199620241111
e38c96d4-ea33-3f1a-e053-2a95a90a0903mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 199620220711
93c4ddcf-ca4f-4a46-a7b7-1395fb0885d2mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21MIRTAZAPINE TABLETS. These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS . MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 199620201111
ea673212-80ab-4a84-8cdc-ff7c5e667c81mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 199620201029
b274a701-d523-3fe3-e053-2995a90ac7e0mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 199620201024
acb2a5f7-3fea-4e57-8c81-becff9f06214mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21MIRTAZAPINE TABLETS, USP 15 mg, 30 mg and 45 mg Rx Only20191205
20a724c6-feba-40e7-a35a-8a37de2e0136mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only20190308
3bda4994-cdf5-47b4-aebc-7297347334e9mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only20180824
5a1ce60e-977b-1801-e053-2a91aa0adb5emirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21479 Mirtazapine 15 mg Mirtazapine Tablets, USP20170926
3000c647-d052-4ebd-a809-39a4a514842dmirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21MIRTAZAPINE20151027
20b2b378-f493-4f57-a5c1-54865d8c0183mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only20140114
1473011e-7c96-482a-83e8-af339cb0b274mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only20130925
dd2f25f6-7688-48e1-92e7-aab152ff7413mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21Mirtazapine Tablets USP Revised: June 2008 Rx only20120723
8feda54f-a3fa-4108-bfc4-c15b0eab4396mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21REMERON ® (mirtazapine)Tablets20120217
2373655d-ac74-43f5-a041-9f41a5b92206mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21Mirtazapine Tablets USP Revised: June 2008 Rx only20111227
18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21Mirtazapine Tablets, USP20101006
912e850f-a0bf-4e07-a800-43479eeffb05mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]2120100630
4801d296-7194-4c8c-895d-0dc1a3e6eb25mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]2120100528
8731e418-0cdb-44d2-b534-382c6467a6b9mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]2120100528
310d8699-2c46-44e8-8c5f-79f01517a4a6mirtazapine 15 MG Oral Tablet [PSN] · mirtazapine 15 MG Oral Tablet [SCD]21Mirtazapine20100525