Duloxetine

Product NDC
68788-7828
11-digit product format
687887828
Labeler code
68788
Product ID
68788-7828_bec0b6d6-e8e1-40c8-ab15-1d3c9606efd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203197
Marketing category
ANDA
Marketing start
2021-01-08
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
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
68788-7828-0EA - Each68788-782872e6feb6-2515-4bd4-bbf7-5a9dd850615b12021-02-05
68788-7828-1EA - Each68788-782848c4c5d6-e10e-4877-8a12-0a95d47f56f212021-02-05
68788-7828-2EA - Each68788-7828676f8a33-2808-46d5-8723-713abb36978f12021-02-05
68788-7828-3EA - Each68788-7828d9ab8489-2a21-46f7-9b4a-ccbfe3b4703312021-02-05
68788-7828-6EA - Each68788-7828936c9b41-17f7-410a-bd10-abdd5cf999f812021-02-05
68788-7828-9EA - Each68788-782872066852-f60a-4d10-91c1-9cce781d5cc912021-02-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7828-0687887828006 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-0) 2021-01-080000-00-00NoNoCurrent
68788-7828-16878878280110 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-1) 2021-01-080000-00-00NoNoCurrent
68788-7828-26878878280220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-2) 2021-01-080000-00-00NoNoCurrent
68788-7828-36878878280330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-3) 2021-01-080000-00-00NoNoCurrent
68788-7828-66878878280660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-6) 2021-01-080000-00-00NoNoCurrent
68788-7828-96878878280990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-9) 2021-01-080000-00-00NoNoCurrent