FDA.reportPublic FDA data

Mirtazapine

Product NDC
70518-1309
11-digit product format
705181309
Labeler code
70518
Product ID
70518-1309_48d4fa9a-4e2b-bbca-e063-6394a90a4c2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076921
Marketing category
ANDA
Marketing start
2018-07-18
Substance
MIRTAZAPINE
Active strength
30 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
MIRTAZAPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui314111

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
70518-1309-0Mirtazapine30 in 1 BLISTER PACKTABLET, FILM COATED3018
70518-1309-1Mirtazapine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3018
70518-1309-2Mirtazapine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3018
70518-1309-3Mirtazapine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1309MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 4 package rows20250510_aae4c58a-5cbd-45ef-b0f9-32bf28204f15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314111mirtazapine 30 MG Oral TabletPSNaae4c58a-5cbd-45ef-b0f9-32bf28204f1518
314111mirtazapine 30 MG Oral TabletSCDaae4c58a-5cbd-45ef-b0f9-32bf28204f1518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1309-07051813090030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1309-0) 2018-07-180000-00-00NoNoCurrent
70518-1309-17051813090130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1309-1) 2020-12-230000-00-00NoNoCurrent
70518-1309-27051813090230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1309-2) 2022-01-110000-00-00NoNoCurrent
70518-1309-37051813090390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1309-3) 2025-05-29NoNoHistorical