GEMFIBROZIL

Product NDC
68071-4053
11-digit product format
680714053
Labeler code
68071
Product ID
68071-4053_d775fcda-1ab5-e852-e053-2995a90aed44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GEMFIBROZIL
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077836
Marketing category
ANDA
Marketing start
2017-03-23
Marketing end
0000-00-00
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4053-12022-02-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-22022-02-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-32022-02-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-62022-02-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-82022-02-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-92022-02-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-12022-01-28C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-22022-01-28C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-32022-01-28C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-62022-01-28C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-82022-01-28C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-92022-01-28C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-12021-01-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-22021-01-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-32021-01-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-62021-01-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-82021-01-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-92021-01-07C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-12020-01-31C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-22020-01-31C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-32020-01-31C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-62020-01-31C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-82020-01-31C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88
68071-4053-92020-01-31C16284748780-19d75b9d0-0799-f424-e053-dadaa90a57ce56e33071-420a-2039-e054-00144ff88e88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4053-168071405301100 TABLET in 1 BOTTLE (68071-4053-1) 100 tablet2017-08-160000-00-00NoNoCurrent
68071-4053-268071405302120 TABLET in 1 BOTTLE (68071-4053-2) 120 tablet2017-08-160000-00-00NoNoCurrent
68071-4053-36807140530330 TABLET in 1 BOTTLE (68071-4053-3) 30 tablet2017-08-160000-00-00NoNoCurrent
68071-4053-66807140530660 TABLET in 1 BOTTLE (68071-4053-6) 60 tablet2017-08-160000-00-00NoNoCurrent
68071-4053-868071405308180 TABLET in 1 BOTTLE (68071-4053-8) 180 tablet2017-08-160000-00-00NoNoCurrent
68071-4053-96807140530990 TABLET in 1 BOTTLE (68071-4053-9) 90 tablet2017-08-160000-00-00NoNoCurrent