Fluoxetine

Product NDC
16714-353
11-digit product format
167140353
Labeler code
16714
Product ID
16714-353_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
40 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
16714-353-01EA - Each16714-353f86139d2-2db3-47fc-b58b-92a6b5afd3fc12012-07-24
16714-353-02EA - Each16714-353504d02e8-b0c5-4834-820d-a5ad3b957c1912012-07-24
16714-353-03EA - Each16714-353ae2bcf51-aeda-4c34-8294-57eae2e8cc4112012-07-24
16714-353-04EA - Each16714-35305e69d65-e359-47f4-b1e8-2394622c504812012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-353-011671403530130 CAPSULE in 1 BOTTLE (16714-353-01) 30 capsule2009-07-010000-00-00NoNoCurrent
16714-353-02167140353021000 CAPSULE in 1 BOTTLE (16714-353-02) 1000 capsule2009-07-010000-00-00NoNoCurrent
16714-353-0316714035303100 CAPSULE in 1 BOTTLE (16714-353-03) 100 capsule2009-07-010000-00-00NoNoCurrent
16714-353-0416714035304500 CAPSULE in 1 BOTTLE (16714-353-04) 500 capsule2009-07-010000-00-00NoNoCurrent