Mirtazapine

Product NDC
0378-3515
11-digit product format
003783515
Labeler code
0378
Product ID
0378-3515_681d9ec4-046b-4c0e-b85f-2468620c724b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076122
Marketing category
ANDA
Marketing start
2003-06-20
Substance
MIRTAZAPINE
Active strength
15 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
Mirtazapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRTAZAPINE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui311725, 311726, 314111

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-3515-01Mirtazapine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10020
0378-3515-10Mirtazapine1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100020
0378-3515-70Mirtazapine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3020
0378-3515-93Mirtazapine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3515-01EA - Each0378-3515f63a3642-0d24-4d79-b686-fb5152582bba12016-06-14
0378-3515-10EA - Each0378-3515f66e2618-43af-4867-96e9-932ad883141712012-07-24
0378-3515-70EA - Each0378-35154a938100-76cd-4f8e-82af-82c1c6413bfa12016-03-04
0378-3515-93EA - Each0378-3515633f7c63-5ccc-4175-8905-f87b21becf4c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
TRIACETININACTIVE INGREDIENTXHX3C3X673MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
TRIACETININACTIVE INGREDIENTXHX3C3X673MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673MIRTAZAPINE TABLET [PHYSICIANS TOTAL CARE, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673MIRTAZAPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3515MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]20Current NDC, Legacy NDC, 4 package rows20221019_711aa80b-8fc6-49e6-9494-3db31d9b53a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN711aa80b-8fc6-49e6-9494-3db31d9b53a420
314111mirtazapine 30 MG Oral TabletPSN711aa80b-8fc6-49e6-9494-3db31d9b53a420
311726mirtazapine 45 MG Oral TabletPSN711aa80b-8fc6-49e6-9494-3db31d9b53a420
311725mirtazapine 15 MG Oral TabletSCD711aa80b-8fc6-49e6-9494-3db31d9b53a420
314111mirtazapine 30 MG Oral TabletSCD711aa80b-8fc6-49e6-9494-3db31d9b53a420
311726mirtazapine 45 MG Oral TabletSCD711aa80b-8fc6-49e6-9494-3db31d9b53a420
311725mirtazapine 15 MG Oral TabletPSN6837b69b-2f86-42cf-b48d-b4a3c7b5413f16
314111mirtazapine 30 MG Oral TabletPSN6837b69b-2f86-42cf-b48d-b4a3c7b5413f16
311726mirtazapine 45 MG Oral TabletPSN6837b69b-2f86-42cf-b48d-b4a3c7b5413f16
311725mirtazapine 15 MG Oral TabletSCD6837b69b-2f86-42cf-b48d-b4a3c7b5413f16
314111mirtazapine 30 MG Oral TabletSCD6837b69b-2f86-42cf-b48d-b4a3c7b5413f16
311726mirtazapine 45 MG Oral TabletSCD6837b69b-2f86-42cf-b48d-b4a3c7b5413f16
311725mirtazapine 15 MG Oral TabletPSNa6a5949f-5ebf-f37d-e053-2995a90adae55
314111mirtazapine 30 MG Oral TabletPSNa6a5949f-5ebf-f37d-e053-2995a90adae55
311726mirtazapine 45 MG Oral TabletPSNa6a5949f-5ebf-f37d-e053-2995a90adae55
311725mirtazapine 15 MG Oral TabletSCDa6a5949f-5ebf-f37d-e053-2995a90adae55
314111mirtazapine 30 MG Oral TabletSCDa6a5949f-5ebf-f37d-e053-2995a90adae55
311726mirtazapine 45 MG Oral TabletSCDa6a5949f-5ebf-f37d-e053-2995a90adae55
311725mirtazapine 15 MG Oral TabletPSN6d2ff278-0c80-4373-b77d-b5f186c4b9913
314111mirtazapine 30 MG Oral TabletPSN6d2ff278-0c80-4373-b77d-b5f186c4b9913
311726mirtazapine 45 MG Oral TabletPSN6d2ff278-0c80-4373-b77d-b5f186c4b9913
311725mirtazapine 15 MG Oral TabletSCD6d2ff278-0c80-4373-b77d-b5f186c4b9913
314111mirtazapine 30 MG Oral TabletSCD6d2ff278-0c80-4373-b77d-b5f186c4b9913
311726mirtazapine 45 MG Oral TabletSCD6d2ff278-0c80-4373-b77d-b5f186c4b9913
311725mirtazapine 15 MG Oral TabletPSN412abf0e-1f96-4d4d-bb56-a23d4699b14c2
311725mirtazapine 15 MG Oral TabletPSN03395e21-ea63-4a4b-b1e0-418c414a35fc2
314111mirtazapine 30 MG Oral TabletPSN03395e21-ea63-4a4b-b1e0-418c414a35fc2
311725mirtazapine 15 MG Oral TabletSCD412abf0e-1f96-4d4d-bb56-a23d4699b14c2
311725mirtazapine 15 MG Oral TabletSCD03395e21-ea63-4a4b-b1e0-418c414a35fc2
314111mirtazapine 30 MG Oral TabletSCD03395e21-ea63-4a4b-b1e0-418c414a35fc2
311725mirtazapine 15 MG Oral TabletPSN310d8699-2c46-44e8-8c5f-79f01517a4a61
311725mirtazapine 15 MG Oral TabletPSN8731e418-0cdb-44d2-b534-382c6467a6b91
311725mirtazapine 15 MG Oral TabletPSN912e850f-a0bf-4e07-a800-43479eeffb051
314111mirtazapine 30 MG Oral TabletPSN310d8699-2c46-44e8-8c5f-79f01517a4a61
314111mirtazapine 30 MG Oral TabletPSN912e850f-a0bf-4e07-a800-43479eeffb051
311726mirtazapine 45 MG Oral TabletPSN912e850f-a0bf-4e07-a800-43479eeffb051
311726mirtazapine 45 MG Oral TabletPSN310d8699-2c46-44e8-8c5f-79f01517a4a61
311725mirtazapine 15 MG Oral TabletSCD912e850f-a0bf-4e07-a800-43479eeffb051
311725mirtazapine 15 MG Oral TabletSCD310d8699-2c46-44e8-8c5f-79f01517a4a61
311725mirtazapine 15 MG Oral TabletSCD8731e418-0cdb-44d2-b534-382c6467a6b91
314111mirtazapine 30 MG Oral TabletSCD912e850f-a0bf-4e07-a800-43479eeffb051
314111mirtazapine 30 MG Oral TabletSCD310d8699-2c46-44e8-8c5f-79f01517a4a61
311726mirtazapine 45 MG Oral TabletSCD912e850f-a0bf-4e07-a800-43479eeffb051
311726mirtazapine 45 MG Oral TabletSCD310d8699-2c46-44e8-8c5f-79f01517a4a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-3515-0100378351501100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3515-01) 2016-08-020000-00-00NoNoCurrent
0378-3515-10003783515101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3515-10) 2003-06-200000-00-00NoNoCurrent
0378-3515-700037835157030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3515-70) 2003-06-202021-10-31NoNoCurrent
0378-3515-930037835159330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3515-93) 2003-06-200000-00-00NoNoCurrent