Atomoxetine

Product NDC: 35573-415
11-digit product format: 355730415
Labeler code: 35573
Product ID: 35573-415_afa582f8-8dc3-4020-81c6-f26a26907eb2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atomoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Burel Pharmaceuticals, LLC
Application: ANDA079016
Marketing category: ANDA
Marketing start: 2017-05-30
Marketing end: 0000-00-00
Substance: ATOMOXETINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35573-415-30	EA - Each	35573-415	a979eacc-2375-4ef4-a332-aaf7c9edd4a2	1	2019-12-10

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57WVB6I2W0	ATOMOXETINE HYDROCHLORIDE	82248-59-7	ATOMOXETINE HYDROCHLORIDE
ASW034S0B8	ATOMOXETINE	83015-26-3	Atomoxetine

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35573-415-30	35573041530	30 CAPSULE in 1 BOTTLE (35573-415-30)	30 capsule	2017-05-30	0000-00-00	No	No	Current