FDA.reportPublic FDA data

Mirtazapine

Product NDC
71335-1332
11-digit product format
713351332
Labeler code
71335
Product ID
71335-1332_9f38fc25-a0a2-44ac-8a25-789b86ed511e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076921
Marketing category
ANDA
Marketing start
2004-10-22
Substance
MIRTAZAPINE
Active strength
45 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mirtazapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRTAZAPINE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui311726

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
71335-1332-1Mirtazapine30 in 1 BOTTLETABLET, FILM COATED30104
71335-1332-2Mirtazapine90 in 1 BOTTLETABLET, FILM COATED90104
71335-1332-3Mirtazapine60 in 1 BOTTLETABLET, FILM COATED60104
71335-1332-4Mirtazapine28 in 1 BOTTLETABLET, FILM COATED28104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1332-1EA - Each71335-13326709aaef-bcb3-47f3-8858-f1967a1faa0412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1332MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 4 package rows20240407_7727fe84-f6cc-4b31-bc00-1ecf741ad361.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311726mirtazapine 45 MG Oral TabletPSN7727fe84-f6cc-4b31-bc00-1ecf741ad361104
311726mirtazapine 45 MG Oral TabletSCD7727fe84-f6cc-4b31-bc00-1ecf741ad361104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1332-17133513320130 TABLET, FILM COATED in 1 BOTTLE (71335-1332-1) 2019-09-050000-00-00NoNoCurrent
71335-1332-27133513320290 TABLET, FILM COATED in 1 BOTTLE (71335-1332-2) 2024-04-030000-00-00NoNoCurrent
71335-1332-37133513320360 TABLET, FILM COATED in 1 BOTTLE (71335-1332-3) 2024-04-030000-00-00NoNoCurrent
71335-1332-47133513320428 TABLET, FILM COATED in 1 BOTTLE (71335-1332-4) 2024-04-030000-00-00NoNoCurrent