FDA.reportPublic FDA data

Mirtazapine

Product NDC
71205-481
11-digit product format
712050481
Labeler code
71205
Product ID
71205-481_cc15149e-2921-468f-a145-513b01885a81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076921
Marketing category
ANDA
Marketing start
2004-10-22
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

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
71205-481-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED302
71205-481-60Mirtazapine60 in 1 BOTTLETABLET, FILM COATED602
71205-481-90Mirtazapine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-481-30EA - Each71205-481d9756d9d-572a-4356-930a-607d24b9c48512021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-481MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220904_0f19ab40-1a30-4ac2-9bd7-c2f8199e29e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN0f19ab40-1a30-4ac2-9bd7-c2f8199e29e12
311725mirtazapine 15 MG Oral TabletSCD0f19ab40-1a30-4ac2-9bd7-c2f8199e29e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-481-307120504813030 TABLET, FILM COATED in 1 BOTTLE (71205-481-30) 2020-10-010000-00-00NoNoCurrent
71205-481-607120504816060 TABLET, FILM COATED in 1 BOTTLE (71205-481-60) 2020-10-010000-00-00NoNoCurrent
71205-481-907120504819090 TABLET, FILM COATED in 1 BOTTLE (71205-481-90) 2020-10-010000-00-00NoNoCurrent