Mirtazapine

Product NDC
67046-481
11-digit product format
670460481
Labeler code
67046
Product ID
67046-481_912e850f-a0bf-4e07-a800-43479eeffb05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA076122
Marketing category
ANDA
Marketing start
2010-06-30
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
15 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ca5a24a-fafa-8fc8-52ac-b403ff18faa5Product name320240216
a733d273-402b-1005-9891-1ac1a9c63703Product name220170724

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-481-302019-10-21C16284748780-1956f9ecf-c10e-621f-e053-dbdaa90a74ad912e850f-a0bf-4e07-a800-43479eeffb05

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-481-30Mirtazapine30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
TRIACETININACTIVE INGREDIENTXHX3C3X673MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-481MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100701_912e850f-a0bf-4e07-a800-43479eeffb05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN912e850f-a0bf-4e07-a800-43479eeffb051
314111mirtazapine 30 MG Oral TabletPSN912e850f-a0bf-4e07-a800-43479eeffb051
311726mirtazapine 45 MG Oral TabletPSN912e850f-a0bf-4e07-a800-43479eeffb051
311725mirtazapine 15 MG Oral TabletSCD912e850f-a0bf-4e07-a800-43479eeffb051
314111mirtazapine 30 MG Oral TabletSCD912e850f-a0bf-4e07-a800-43479eeffb051
311726mirtazapine 45 MG Oral TabletSCD912e850f-a0bf-4e07-a800-43479eeffb051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-481-306704604813030 in 1 BLISTER PACKHistorical