Mirtazapine

Product NDC
21695-083
11-digit product format
216950083
Labeler code
21695
Product ID
21695-083_18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA076921
Marketing category
ANDA
Marketing start
2004-10-22
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
45 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
21695-083-302019-09-24C16284748780-1934fe258-4a16-48b1-e053-8cdaa90a720aMirtazapine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-083-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-083MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20110414_18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81
314111mirtazapine 30 MG Oral TabletPSN18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81
311726mirtazapine 45 MG Oral TabletPSN18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81
311725mirtazapine 15 MG Oral TabletSCD18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81
314111mirtazapine 30 MG Oral TabletSCD18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81
311726mirtazapine 45 MG Oral TabletSCD18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-083-302169500833030 in 1 BOTTLEHistorical