Mirtazapine

Product NDC: 60687-584
11-digit product format: 606870584
Labeler code: 60687
Product ID: 60687-584_2b24b256-28e5-28e1-e063-6294a90a8d89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA076921
Marketing category: ANDA
Marketing start: 2022-08-29
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
60687-584-11	Mirtazapine	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		5
60687-584-21	Mirtazapine	30 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-584-11	EA - Each	60687-584	23b1f439-6d47-4e24-8bc6-b118a0375ceb	1	2022-08-04
60687-584-21	EA - Each	60687-584	d7f550f0-5568-4ab5-ba28-13fd1a08a2f7	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-584	MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5	Current NDC, Legacy NDC, 2 package rows	20250109_3b7a5f44-8da6-4196-bb5d-8d2770af1b3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
476809	mirtazapine 7.5 MG Oral Tablet	PSN	3b7a5f44-8da6-4196-bb5d-8d2770af1b3a	5
476809	mirtazapine 7.5 MG Oral Tablet	SCD	3b7a5f44-8da6-4196-bb5d-8d2770af1b3a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-584-11	60687058411	1 in 1 BLISTER PACK						Historical
60687-584-21	60687058421	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-584-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-584-11)	30 blister pack	2022-08-29	0000-00-00	No	No	Current