Mirtazapine

Product NDC
53808-0735
11-digit product format
538080735
Labeler code
53808
Product ID
53808-0735_63cbcedb-7dfd-4ec5-ae64-d6c87e1b2b5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIRTAZAPINE
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA076541
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
15 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0735-12019-10-21C16284748780-1956f9ecf-c8af-621f-e053-dbdaa90a74ad4801d296-7194-4c8c-895d-0dc1a3e6eb25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0735-1Mirtazapine30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0735MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100614_4801d296-7194-4c8c-895d-0dc1a3e6eb25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN4801d296-7194-4c8c-895d-0dc1a3e6eb251
314111mirtazapine 30 MG Oral TabletPSN4801d296-7194-4c8c-895d-0dc1a3e6eb251
311726mirtazapine 45 MG Oral TabletPSN4801d296-7194-4c8c-895d-0dc1a3e6eb251
311725mirtazapine 15 MG Oral TabletSCD4801d296-7194-4c8c-895d-0dc1a3e6eb251
314111mirtazapine 30 MG Oral TabletSCD4801d296-7194-4c8c-895d-0dc1a3e6eb251
311726mirtazapine 45 MG Oral TabletSCD4801d296-7194-4c8c-895d-0dc1a3e6eb251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0735-15380807350130 in 1 BLISTER PACKHistorical