TENOFOVIR DISOPROXIL FUMARATE

Product NDC
70518-1002
11-digit product format
705181002
Labeler code
70518
Product ID
70518-1002_cf2f3048-a547-7cf0-e053-2a95a90a2250
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tenofovir disoproxil fumarate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090742
Marketing category
ANDA
Marketing start
2018-02-02
Marketing end
0000-00-00
Substance
TENOFOVIR DISOPROXIL FUMARATE
Active strength
300 mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1002-02023-01-31C16284748780-1f386c649-c912-0266-e053-dadaa90a7c1a5b3f94f4-1846-4b8f-9f95-416c2997a0a8
70518-1002-12023-01-31C16284748780-1f386c649-c912-0266-e053-dadaa90a7c1a5b3f94f4-1846-4b8f-9f95-416c2997a0a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1002-07051810020030 TABLET in 1 BLISTER PACK (70518-1002-0) 30 tablet2018-02-020000-00-00NoNoCurrent
70518-1002-1705181002014 TABLET in 1 BLISTER PACK (70518-1002-1) 4 tablet2019-01-310000-00-00NoNoCurrent