FDA.reportPublic FDA data

NDC 80425-0305-01 - Mirtazapine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0305
Requested NDC
80425-0305-01
Package NDCs from labels
80425-0305-1, 80425-0305-2, 80425-0305-3, 80425-0305-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mirtazapine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0305-1Mirtazapine30 in 1 BOTTLETABLET, FILM COATED302
80425-0305-2Mirtazapine60 in 1 BOTTLETABLET, FILM COATED602
80425-0305-3Mirtazapine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0305MIRTAZAPINE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8c383c1-d1b3-ceaa-e053-6294a90a6053.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0305-1EA - Each80425-0305d0b976ed-648c-4682-9747-c9c828babd9812023-06-06
80425-0305-2EA - Each80425-0305ae63789d-7e87-4a5b-a0b0-e6fb725b081f12023-06-06
80425-0305-3EA - Each80425-0305945dc0c0-5ddc-4cfa-84b4-a8f1b992e11212023-06-06

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 5 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINEProficient Rx LPa2f01ffd-fd48-499b-9126-8eb9048a57222022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314111
unii: A051Q2099Q
MirtazapineMIRTAZAPINESun Pharmaceutical Industries, Inc.f23631be-c7ae-46e9-b771-a70be17bc9f02021-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 476809
rxcui: 311726
rxcui: 311725
rxcui: 314111
unii: A051Q2099Q
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC500dbfbe-2a00-496d-9e44-6e59d2c68ea22021-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314111
unii: A051Q2099Q
MirtazapineMIRTAZAPINEProficient Rx LPa96e0d95-1a7b-4588-923a-2169b55062032021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076921
rxcui: 314111
unii: A051Q2099Q
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC93c4ddcf-ca4f-4a46-a7b7-1395fb0885d22020-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
unii: A051Q2099Q
MirtazapineMIRTAZAPINENCS HealthCare of KY, Inc dba Vangard Labs20a724c6-feba-40e7-a35a-8a37de2e01362019-03-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076921
rxcui: 311725
rxcui: 314111
unii: A051Q2099Q
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC3bda4994-cdf5-47b4-aebc-7297347334e92018-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076921
rxcui: 311725
unii: A051Q2099Q
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC6ad0e695-92ee-4900-b194-a2455473370b2018-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076921
rxcui: 314111
unii: A051Q2099Q

Reported adverse events (FAERS/openFDA)#

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