Mirtazapine

Product NDC: 70518-4548
11-digit product format: 705184548
Labeler code: 70518
Product ID: 70518-4548_48bdcb5d-498e-4412-e063-6394a90ad87f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA076541
Marketing category: ANDA
Marketing start: 2026-01-18
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
Ingredient	Strength
MIRTAZAPINE	30 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	A051Q2099Q
Rxcui	314111

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
70518-4548-0	Mirtazapine	30 in 1 BOTTLE, PLASTIC	TABLET	30		1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314111	mirtazapine 30 MG Oral Tablet	PSN	e708e8bb-9b13-44d9-96f5-fd73a893a987	1
314111	mirtazapine 30 MG Oral Tablet	SCD	e708e8bb-9b13-44d9-96f5-fd73a893a987	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4548-0	70518454800	30 TABLET in 1 BOTTLE, PLASTIC (70518-4548-0)	30 tablet	2026-01-18	No	No	Historical