FDA.reportPublic FDA data

NDC 73377-090 - Mirtazapine Anhydrous

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
73377-090
Package NDCs from labels
73377-090-01, 73377-090-02, 73377-090-04
Manufacturer
AX Pharmaceutical Corp
Effective date
2024-10-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mirtazapine Anhydrous - AX Pharmaceutical CorpAX Pharmaceutical Corp2024-10-17BULK INGREDIENT - ANIMAL DRUG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73377-090-01Mirtazapine Anhydrous25 g in 1 JARPOWDER253
73377-090-02Mirtazapine Anhydrous50 g in 1 JARPOWDER503
73377-090-04Mirtazapine Anhydrous500 g in 1 JARPOWDER5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73377-090MIRTAZAPINE ANHYDROUS POWDER [AX PHARMACEUTICAL CORP]33 package rows20241019_a64fae29-737d-4f42-a55e-55fbe0ed7d71.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 5 of 5 · 90 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINEProficient Rx LP3b516a33-b164-4e4f-bc18-e9d1e591323a2022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
MirtazapineMIRTAZAPINEProficient Rx LP0f19ab40-1a30-4ac2-9bd7-c2f8199e29e12022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
MirtazapineMIRTAZAPINEProficient Rx LPa2f01ffd-fd48-499b-9126-8eb9048a57222022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
MirtazapineMIRTAZAPINESun Pharmaceutical Industries, Inc.f23631be-c7ae-46e9-b771-a70be17bc9f02021-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC500dbfbe-2a00-496d-9e44-6e59d2c68ea22021-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
MirtazapineMIRTAZAPINEProficient Rx LPa96e0d95-1a7b-4588-923a-2169b55062032021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC93c4ddcf-ca4f-4a46-a7b7-1395fb0885d22020-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
MirtazapineMIRTAZAPINENCS HealthCare of KY, Inc dba Vangard Labs20a724c6-feba-40e7-a35a-8a37de2e01362019-03-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC3bda4994-cdf5-47b4-aebc-7297347334e92018-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC6ad0e695-92ee-4900-b194-a2455473370b2018-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A051Q2099Q

Reported adverse events (FAERS/openFDA)#

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