FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
68071-2565
11-digit product format
680712565
Labeler code
68071
Product ID
68071-2565_cffe01a3-cd43-3ff2-e053-2995a90adc02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209421
Marketing category
ANDA
Marketing start
2018-10-05
Marketing end
0000-00-00
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2565-12025-01-30C16284748780-1f386c649-d104-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULE safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULE. OSELTAMIVIR PHOSPHATE capsule, for oral use Initial U.S. Approval: 1999
68071-2565-12023-07-17C16284748780-1f386c649-d104-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULE safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULE. OSELTAMIVIR PHOSPHATE capsule, for oral use Initial U.S. Approval: 1999
68071-2565-12023-01-30C16284748780-1f386c649-d104-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULE safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULE. OSELTAMIVIR PHOSPHATE capsule, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2565-1Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2565OSELTAMIVIR PHOSPHATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20230718_cffe01a3-cd42-3ff2-e053-2995a90adc02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSNcffe01a3-cd42-3ff2-e053-2995a90adc022
312122oseltamivir 75 MG Oral CapsuleSCDcffe01a3-cd42-3ff2-e053-2995a90adc022
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYcffe01a3-cd42-3ff2-e053-2995a90adc022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2565-16807125650110 CAPSULE in 1 BLISTER PACK (68071-2565-1) 10 capsule2021-11-040000-00-00NoNoCurrent