FDA.reportPublic FDA data

Mirtazapine

Product NDC
60505-0249
11-digit product format
605050249
Labeler code
60505
Product ID
60505-0249_c076cd92-b06d-b317-cc04-6f99b3718cf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA077666
Marketing category
ANDA
Marketing start
2007-08-22
Substance
MIRTAZAPINE
Active strength
45 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
MIRTAZAPINE45 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
60505-0249-1Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3020
60505-0249-3Mirtazapine100 in 1 BOTTLETABLET, FILM COATED10020
60505-0249-5Mirtazapine500 in 1 BOTTLETABLET, FILM COATED50020
60505-0249-8Mirtazapine1000 in 1 BOTTLETABLET, FILM COATED100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0249-1EA - Each60505-024965fb1cdb-7bae-4e9b-a613-25b6e209654612013-02-13
60505-0249-8EA - Each60505-02494b74bdf0-da15-4f0c-b688-b90dd4c5279012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]4
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSE 2910 (6 CPS)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TRIACETININACTIVE INGREDIENTXHX3C3X673MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0249MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]19Current NDC, Legacy NDC, 4 package rows20241105_9675333e-3064-c8cb-a4b4-6c74d9a82f17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN9675333e-3064-c8cb-a4b4-6c74d9a82f1720
314111mirtazapine 30 MG Oral TabletPSN9675333e-3064-c8cb-a4b4-6c74d9a82f1720
311726mirtazapine 45 MG Oral TabletPSN9675333e-3064-c8cb-a4b4-6c74d9a82f1720
311725mirtazapine 15 MG Oral TabletSCD9675333e-3064-c8cb-a4b4-6c74d9a82f1720
314111mirtazapine 30 MG Oral TabletSCD9675333e-3064-c8cb-a4b4-6c74d9a82f1720
311726mirtazapine 45 MG Oral TabletSCD9675333e-3064-c8cb-a4b4-6c74d9a82f1720
311726mirtazapine 45 MG Oral TabletPSN82a644f9-d9f6-4398-83db-8a1446c183e05
311726mirtazapine 45 MG Oral TabletSCD82a644f9-d9f6-4398-83db-8a1446c183e05
311725mirtazapine 15 MG Oral TabletPSN3b516a33-b164-4e4f-bc18-e9d1e591323a4
311726mirtazapine 45 MG Oral TabletPSN3b516a33-b164-4e4f-bc18-e9d1e591323a4
311725mirtazapine 15 MG Oral TabletSCD3b516a33-b164-4e4f-bc18-e9d1e591323a4
311726mirtazapine 45 MG Oral TabletSCD3b516a33-b164-4e4f-bc18-e9d1e591323a4
311725mirtazapine 15 MG Oral TabletPSN34c0b734-98ca-4aec-965f-e55edd3317f32
314111mirtazapine 30 MG Oral TabletPSN34c0b734-98ca-4aec-965f-e55edd3317f32
311726mirtazapine 45 MG Oral TabletPSN34c0b734-98ca-4aec-965f-e55edd3317f32
311726mirtazapine 45 MG Oral TabletPSNe7f84b73-ec3f-4638-b5a7-e0feafbe92772
311725mirtazapine 15 MG Oral TabletSCD34c0b734-98ca-4aec-965f-e55edd3317f32
314111mirtazapine 30 MG Oral TabletSCD34c0b734-98ca-4aec-965f-e55edd3317f32
311726mirtazapine 45 MG Oral TabletSCD34c0b734-98ca-4aec-965f-e55edd3317f32
311726mirtazapine 45 MG Oral TabletSCDe7f84b73-ec3f-4638-b5a7-e0feafbe92772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0249-16050502490130 TABLET, FILM COATED in 1 BOTTLE (60505-0249-1) 2007-08-220000-00-00NoNoCurrent
60505-0249-360505024903100 TABLET, FILM COATED in 1 BOTTLE (60505-0249-3) 2007-08-220000-00-00NoNoCurrent
60505-0249-560505024905500 TABLET, FILM COATED in 1 BOTTLE (60505-0249-5) 2007-08-220000-00-00NoNoCurrent
60505-0249-8605050249081000 TABLET, FILM COATED in 1 BOTTLE (60505-0249-8) 2007-08-220000-00-00NoNoCurrent