FDA.reportPublic FDA data

Tamiflu

Product NDC
0004-0822
11-digit product format
000040822
Labeler code
0004
Product ID
0004-0822_94a312ac-c47a-4437-8dd3-6bcd7e08e42c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA021246
Marketing category
NDA
Marketing start
2011-03-21
Substance
OSELTAMIVIR PHOSPHATE
Active strength
6 mg/mL
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 PHOSPHATE6 mg/mL

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0004-0822-05Tamiflu1 in 1 CARTONPOWDER, FOR SUSPENSION145
0004-0822-05Tamiflu60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION6045

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0004-0822-05ML - Milliliter0004-08221a7ccd8a-c7bb-4981-8fa0-ff9ab0bdc49612013-09-04

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
0004-0822TAMIFLU (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
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN247fb507-b3a1-4005-abb9-d17774fa29968
1115700Tamiflu 6 MG in 1 mL Oral SuspensionPSN247fb507-b3a1-4005-abb9-d17774fa29968
1115700oseltamivir 6 MG/ML Oral Suspension [Tamiflu]SBD247fb507-b3a1-4005-abb9-d17774fa29968
1115698oseltamivir 6 MG/ML Oral SuspensionSCD247fb507-b3a1-4005-abb9-d17774fa29968
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY247fb507-b3a1-4005-abb9-d17774fa29968
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY247fb507-b3a1-4005-abb9-d17774fa29968
1115700Tamiflu 6 MG per 1 ML Oral SuspensionSY247fb507-b3a1-4005-abb9-d17774fa29968
1115700Tamiflu 6 MG/ML Oral SuspensionSY247fb507-b3a1-4005-abb9-d17774fa29968

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0004-0822-05000040822051 BOTTLE, GLASS in 1 CARTON (0004-0822-05) / 60 mL in 1 BOTTLE, GLASS2011-03-210000-00-00NoNoCurrent