FDA.reportPublic FDA data

Mirtazapine

Product NDC
51407-352
11-digit product format
514070352
Labeler code
51407
Product ID
51407-352_1ae118fb-af9e-fc47-e063-6394a90ad910
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA076122
Marketing category
ANDA
Marketing start
2003-06-19
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
51407-352-05Mirtazapine500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5005
51407-352-30Mirtazapine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-352-05EA - Each51407-352364b5165-5a47-4003-9aa3-7fc6ce2a497e12020-07-13
51407-352-30EA - Each51407-3528d05daa0-a1e9-4cc2-add9-4a2b4e571fda12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-352MIRTAZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]5Current NDC, Legacy NDC, 2 package rows20240616_a6a5949f-5ebf-f37d-e053-2995a90adae5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-352-0551407035205500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-352-05) 2020-02-210000-00-00NoNoCurrent
51407-352-305140703523030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-352-30) 2020-02-210000-00-00NoNoCurrent