FDA.reportPublic FDA data

oseltamavir phosphate

Product NDC
68071-4739
11-digit product format
680714739
Labeler code
68071
Product ID
68071-4739_2d7d2d42-1baa-e20a-e063-6394a90a15cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamavir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207211
Marketing category
ANDA
Marketing start
2017-09-21
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
oseltamavir phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ
Rxcui312122

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
68071-4739-12024-06-12C16284748780-1ba0f9c33-5219-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES. OSELTAMIVIR PHOSPHATE capsules, for oral use Initial U.S. Approval: 1999
68071-4739-12023-01-30C16284748780-1ba0f9c33-5219-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES. OSELTAMIVIR PHOSPHATE capsules, for oral use Initial U.S. Approval: 1999
68071-4739-12021-02-17C16284748780-1ba0f9c33-5219-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES. OSELTAMIVIR PHOSPHATE capsules, for oral use Initial U.S. Approval: 1999
68071-4739-12021-01-29C16284748780-1ba0f9c33-5219-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES. OSELTAMIVIR PHOSPHATE capsules, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4739-1oseltamavir phosphate10 in 1 BOXCAPSULE105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4739OSELTAMAVIR PHOSPHATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20250209_80511c6f-88b9-62d3-e053-2991aa0ab936.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN80511c6f-88b9-62d3-e053-2991aa0ab9365
312122oseltamivir 75 MG Oral CapsuleSCD80511c6f-88b9-62d3-e053-2991aa0ab9365
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY80511c6f-88b9-62d3-e053-2991aa0ab9365

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4739-16807147390110 CAPSULE in 1 BOX (68071-4739-1) 10 capsule2019-01-250000-00-00NoNoCurrent