FDA.reportPublic FDA data

Mirtazapine

Product NDC
65862-003
11-digit product format
658620003
Labeler code
65862
Product ID
65862-003_e26778b1-5226-4107-9d12-3e8b7038bccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA076921
Marketing category
ANDA
Marketing start
2004-10-22
Substance
MIRTAZAPINE
Active strength
30 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
MIRTAZAPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui311725, 311726, 314111, 476809

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
65862-003-01Mirtazapine100 in 1 BOTTLETABLET, FILM COATED10019
65862-003-05Mirtazapine500 in 1 BOTTLETABLET, FILM COATED50019
65862-003-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3019
65862-003-32Mirtazapine30 in 1 BLISTER PACKTABLET, FILM COATED3019
65862-003-60Mirtazapine60 in 1 BOTTLETABLET, FILM COATED6019
65862-003-90Mirtazapine90 in 1 BOTTLETABLET, FILM COATED9019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-003MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]18Current NDC, Legacy NDC, 6 package rows20240126_a4c012f0-50b6-42fb-9f06-a14632f23f2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSNa4c012f0-50b6-42fb-9f06-a14632f23f2e19
314111mirtazapine 30 MG Oral TabletPSNa4c012f0-50b6-42fb-9f06-a14632f23f2e19
311726mirtazapine 45 MG Oral TabletPSNa4c012f0-50b6-42fb-9f06-a14632f23f2e19
476809mirtazapine 7.5 MG Oral TabletPSNa4c012f0-50b6-42fb-9f06-a14632f23f2e19
311725mirtazapine 15 MG Oral TabletSCDa4c012f0-50b6-42fb-9f06-a14632f23f2e19
314111mirtazapine 30 MG Oral TabletSCDa4c012f0-50b6-42fb-9f06-a14632f23f2e19
311726mirtazapine 45 MG Oral TabletSCDa4c012f0-50b6-42fb-9f06-a14632f23f2e19
476809mirtazapine 7.5 MG Oral TabletSCDa4c012f0-50b6-42fb-9f06-a14632f23f2e19
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-003-0165862000301100 TABLET, FILM COATED in 1 BOTTLE (65862-003-01) 2004-10-220000-00-00NoNoCurrent
65862-003-0565862000305500 TABLET, FILM COATED in 1 BOTTLE (65862-003-05) 2004-10-220000-00-00NoNoCurrent
65862-003-306586200033030 TABLET, FILM COATED in 1 BOTTLE (65862-003-30) 2004-10-220000-00-00NoNoCurrent
65862-003-326586200033230 TABLET, FILM COATED in 1 BLISTER PACK (65862-003-32) 2004-10-220000-00-00NoNoCurrent
65862-003-59658620003595000 TABLET, FILM COATED in 1 BAG (65862-003-59)22-OCT-04Current
65862-003-606586200036060 TABLET, FILM COATED in 1 BOTTLE (65862-003-60) 2004-10-220000-00-00NoNoCurrent
65862-003-906586200039090 TABLET, FILM COATED in 1 BOTTLE (65862-003-90) 2004-10-220000-00-00NoNoCurrent