FDA.reportPublic FDA data

Mirtazapine

Product NDC
71335-0286
11-digit product format
713350286
Labeler code
71335
Product ID
71335-0286_7bcab2eb-126f-4e34-949a-a7002e06ed12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076541
Marketing category
ANDA
Marketing start
2004-04-22
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
71335-0286-1Mirtazapine30 in 1 BOTTLETABLET307
71335-0286-2Mirtazapine60 in 1 BOTTLETABLET607
71335-0286-3Mirtazapine90 in 1 BOTTLETABLET907
71335-0286-4Mirtazapine120 in 1 BOTTLETABLET1207
71335-0286-5Mirtazapine15 in 1 BOTTLETABLET157
71335-0286-6Mirtazapine180 in 1 BOTTLETABLET1807
71335-0286-7Mirtazapine45 in 1 BOTTLETABLET457
71335-0286-8Mirtazapine21 in 1 BOTTLETABLET217

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0286-1EA - Each71335-02867cd028ef-7783-408e-a454-9496d9ba89fd12023-12-05
71335-0286-2EA - Each71335-028677aa45f1-6467-4f57-a034-462e1d6ac0e612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0286MIRTAZAPINE TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 8 package rows20231027_9f0f52e8-3318-4da2-b0d9-ea3d33bfe41e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN9f0f52e8-3318-4da2-b0d9-ea3d33bfe41e7
311725mirtazapine 15 MG Oral TabletSCD9f0f52e8-3318-4da2-b0d9-ea3d33bfe41e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0286-17133502860130 TABLET in 1 BOTTLE (71335-0286-1) 30 tablet2021-09-090000-00-00NoNoCurrent
71335-0286-27133502860260 TABLET in 1 BOTTLE (71335-0286-2) 60 tablet2021-11-080000-00-00NoNoCurrent
71335-0286-37133502860390 TABLET in 1 BOTTLE (71335-0286-3) 90 tablet2021-12-270000-00-00NoNoCurrent
71335-0286-471335028604120 TABLET in 1 BOTTLE (71335-0286-4) 120 tablet2021-12-270000-00-00NoNoCurrent
71335-0286-57133502860515 TABLET in 1 BOTTLE (71335-0286-5) 15 tablet2021-12-270000-00-00NoNoCurrent
71335-0286-671335028606180 TABLET in 1 BOTTLE (71335-0286-6) 180 tablet2021-12-270000-00-00NoNoCurrent
71335-0286-77133502860745 TABLET in 1 BOTTLE (71335-0286-7) 45 tablet2021-12-270000-00-00NoNoCurrent
71335-0286-87133502860821 TABLET in 1 BOTTLE (71335-0286-8) 21 tablet2021-12-270000-00-00NoNoCurrent