FDA.reportPublic FDA data

Mirtazapine

Product NDC
71335-0664
11-digit product format
713350664
Labeler code
71335
Product ID
71335-0664_4a352bef-c4c5-4ce4-aca3-05d53469518b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076921
Marketing category
ANDA
Marketing start
2009-08-17
Substance
MIRTAZAPINE
Active strength
15 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
MIRTAZAPINE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui311725

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
71335-0664-1Mirtazapine30 in 1 BOTTLETABLET, FILM COATED309
71335-0664-2Mirtazapine60 in 1 BOTTLETABLET, FILM COATED609
71335-0664-3Mirtazapine90 in 1 BOTTLETABLET, FILM COATED909
71335-0664-4Mirtazapine120 in 1 BOTTLETABLET, FILM COATED1209
71335-0664-5Mirtazapine15 in 1 BOTTLETABLET, FILM COATED159
71335-0664-6Mirtazapine180 in 1 BOTTLETABLET, FILM COATED1809
71335-0664-7Mirtazapine45 in 1 BOTTLETABLET, FILM COATED459
71335-0664-8Mirtazapine21 in 1 BOTTLETABLET, FILM COATED219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0664-1EA - Each71335-06649fb969ac-8aed-4502-80a4-dbbd7437be2612021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0664MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 8 package rows20240412_beaa0678-e4b9-4241-8b08-e69e2e49530f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSNbeaa0678-e4b9-4241-8b08-e69e2e49530f9
311725mirtazapine 15 MG Oral TabletSCDbeaa0678-e4b9-4241-8b08-e69e2e49530f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0664-17133506640130 TABLET, FILM COATED in 1 BOTTLE (71335-0664-1) 2019-05-310000-00-00NoNoCurrent
71335-0664-27133506640260 TABLET, FILM COATED in 1 BOTTLE (71335-0664-2) 2019-09-110000-00-00NoNoCurrent
71335-0664-37133506640390 TABLET, FILM COATED in 1 BOTTLE (71335-0664-3) 2019-09-130000-00-00NoNoCurrent
71335-0664-471335066404120 TABLET, FILM COATED in 1 BOTTLE (71335-0664-4) 2024-04-030000-00-00NoNoCurrent
71335-0664-57133506640515 TABLET, FILM COATED in 1 BOTTLE (71335-0664-5) 2021-11-180000-00-00NoNoCurrent
71335-0664-671335066406180 TABLET, FILM COATED in 1 BOTTLE (71335-0664-6) 2024-04-030000-00-00NoNoCurrent
71335-0664-77133506640745 TABLET, FILM COATED in 1 BOTTLE (71335-0664-7) 2024-04-030000-00-00NoNoCurrent
71335-0664-87133506640821 TABLET, FILM COATED in 1 BOTTLE (71335-0664-8) 2024-04-030000-00-00NoNoCurrent