Fluoxetine

Product NDC
35356-728
11-digit product format
353560728
Labeler code
35356
Product ID
35356-728_11ef7f63-df75-4b12-b246-dff87be2d877
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA078619
Marketing category
ANDA
Marketing start
2008-01-31
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin 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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-728-00EA - Each35356-72808d5e8b2-16ee-400e-9b02-429b713f2dfd12014-07-02
35356-728-15EA - Each35356-728fad32484-d5c8-4533-9fa9-88cdfd82291412013-07-02
35356-728-30EA - Each35356-72899a0a080-7146-4075-9c6d-fcdeb017901b12013-02-13
35356-728-60EA - Each35356-728a8be5b41-03ca-4f5a-b7ae-5d90d67ff6d712015-02-02
35356-728-90EA - Each35356-7286911ed0c-c4cf-4bd9-803f-1f40da6c6d8d12014-01-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-728-0035356072800100 CAPSULE in 1 BOTTLE (35356-728-00) 100 capsule2008-01-310000-00-00NoNoCurrent
35356-728-143535607281414 CAPSULE in 1 BOTTLE (35356-728-14) 14 capsule2008-01-310000-00-00NoNoCurrent
35356-728-153535607281515 CAPSULE in 1 BOTTLE (35356-728-15) 15 capsule2008-01-310000-00-00NoNoCurrent
35356-728-203535607282020 CAPSULE in 1 BOTTLE (35356-728-20) 20 capsule2008-01-310000-00-00NoNoCurrent
35356-728-303535607283030 CAPSULE in 1 BOTTLE (35356-728-30) 30 capsule2008-01-310000-00-00NoNoCurrent
35356-728-603535607286060 CAPSULE in 1 BOTTLE (35356-728-60) 60 capsule2008-01-310000-00-00NoNoCurrent
35356-728-903535607289090 CAPSULE in 1 BOTTLE (35356-728-90) 90 capsule2008-01-310000-00-00NoNoCurrent