FDA.reportPublic FDA data

Tamiflu

Product NDC
0004-0802
11-digit product format
000040802
Labeler code
0004
Product ID
0004-0802_94a312ac-c47a-4437-8dd3-6bcd7e08e42c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA021087
Marketing category
NDA
Marketing start
1999-10-27
Substance
OSELTAMIVIR PHOSPHATE
Active strength
30 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
Tamiflu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ
Rxcui261315, 312122, 728109, 728111, 728113, 728115, 1115698, 1115700

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
0004-0802-852024-12-11C16284748780-11e7a6dab-1d76-a2ce-e063-dadaa90aadf7These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU ® (oseltamivir phosphate) capsules, for oral use TAMIFLU ® (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999
0004-0802-852024-07-30C16284748780-11e7a6dab-1d76-a2ce-e063-dadaa90aadf7These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU ® (oseltamivir phosphate) capsules, for oral use TAMIFLU ® (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0004-0802-85Tamiflu10 in 1 BLISTER PACKCAPSULE1045
0004-0802-85Tamiflu1 in 1 CARTONCAPSULE145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0004-0802-85EA - Each0004-08020a5c869b-4cac-4c70-970b-b2c6c668f6a312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oseltamivir PhosphateACTIVE INGREDIENT4A3O49NGEZTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
Oseltamivir CarboxylateACTIVE MOIETYK6106LV5Q8TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
ferric oxide redINACTIVE INGREDIENT1K09F3G675TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
gelatinINACTIVE INGREDIENT2G86QN327LTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
monosodium citrateINACTIVE INGREDIENT68538UP9SETAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
povidone k30INACTIVE INGREDIENTU725QWY32XTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
sodium stearyl fumarateINACTIVE INGREDIENT7CV7WJK4UITAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
sorbitolINACTIVE INGREDIENT506T60A25RTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
starch, cornINACTIVE INGREDIENTO8232NY3SJTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
talcINACTIVE INGREDIENT7SEV7J4R1UTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
xanthan gumINACTIVE INGREDIENTTTV12P4NEETAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0004-0802TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION [GENENTECH, INC.]44Current NDC, Legacy NDC, 2 package rows20241213_ee3c9555-60f2-4f82-a760-11983c86e97b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
728113oseltamivir phosphate 45 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSNee3c9555-60f2-4f82-a760-11983c86e97b45
312122oseltamivir phosphate 75 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
728111Tamiflu 30 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
728115Tamiflu 45 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
1115700Tamiflu 6 MG in 1 mL Oral SuspensionPSNee3c9555-60f2-4f82-a760-11983c86e97b45
261315Tamiflu 75 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
728111oseltamivir 30 MG Oral Capsule [Tamiflu]SBDee3c9555-60f2-4f82-a760-11983c86e97b45
728115oseltamivir 45 MG Oral Capsule [Tamiflu]SBDee3c9555-60f2-4f82-a760-11983c86e97b45
1115700oseltamivir 6 MG/ML Oral Suspension [Tamiflu]SBDee3c9555-60f2-4f82-a760-11983c86e97b45
261315oseltamivir 75 MG Oral Capsule [Tamiflu]SBDee3c9555-60f2-4f82-a760-11983c86e97b45
728109oseltamivir 30 MG Oral CapsuleSCDee3c9555-60f2-4f82-a760-11983c86e97b45
728113oseltamivir 45 MG Oral CapsuleSCDee3c9555-60f2-4f82-a760-11983c86e97b45
1115698oseltamivir 6 MG/ML Oral SuspensionSCDee3c9555-60f2-4f82-a760-11983c86e97b45
312122oseltamivir 75 MG Oral CapsuleSCDee3c9555-60f2-4f82-a760-11983c86e97b45
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSYee3c9555-60f2-4f82-a760-11983c86e97b45
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSYee3c9555-60f2-4f82-a760-11983c86e97b45
728111Tamiflu 30 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45
728115Tamiflu 45 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45
1115700Tamiflu 6 MG per 1 ML Oral SuspensionSYee3c9555-60f2-4f82-a760-11983c86e97b45
1115700Tamiflu 6 MG/ML Oral SuspensionSYee3c9555-60f2-4f82-a760-11983c86e97b45
261315Tamiflu 75 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0004-0802-85000040802851 BLISTER PACK in 1 CARTON (0004-0802-85) / 10 CAPSULE in 1 BLISTER PACK1 blister pack1999-10-270000-00-00NoNoCurrent