Fluoxetine

Product NDC
16714-351
11-digit product format
167140351
Labeler code
16714
Product ID
16714-351_d95ab480-76f2-45d0-9c2a-a164cc1f4f5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA090223
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-351-01EA - Each16714-3510cf30bf2-3bfb-40b6-8727-0cb06ab48b2712012-07-24
16714-351-02EA - Each16714-35108f2b097-969e-4fa5-907f-ebec6386e3a812012-07-24
16714-351-03EA - Each16714-351c3abf0cf-1951-4633-bd7c-0aee646ad80212012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-351-011671403510130 CAPSULE in 1 BOTTLE (16714-351-01) 30 capsule2009-07-010000-00-00NoNoCurrent
16714-351-02167140351021000 CAPSULE in 1 BOTTLE (16714-351-02) 1000 capsule2009-07-010000-00-00NoNoCurrent
16714-351-0316714035103100 CAPSULE in 1 BOTTLE (16714-351-03) 100 capsule2009-07-010000-00-00NoNoCurrent