Mirtazapine

Product NDC: 71335-3038
11-digit product format: 713353038
Labeler code: 71335
Product ID: 71335-3038_0c65a448-a721-41b5-9545-a5e90b83cda3
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: 7.5 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
Ingredient	Strength
MIRTAZAPINE	7.5 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	A051Q2099Q
Rxcui	476809

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ca5a24a-fafa-8fc8-52ac-b403ff18faa5	Product name	3	20240216
a733d273-402b-1005-9891-1ac1a9c63703	Product name	2	20170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-3038-1	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-3038-1	EA - Each	71335-3038	897c18be-3589-4c6a-8cf7-5ddecf1b415a	1	2026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
476809	mirtazapine 7.5 MG Oral Tablet	PSN	c2b38cc5-7738-44fa-9bef-89a18a1039b2	100
476809	mirtazapine 7.5 MG Oral Tablet	SCD	c2b38cc5-7738-44fa-9bef-89a18a1039b2	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-3038-1	71335303801	30 TABLET, FILM COATED in 1 BOTTLE (71335-3038-1)	2025-12-03	No	No	Historical