FDA.reportPublic FDA data

Tamiflu

Product NDC
0004-0800
11-digit product format
000040800
Labeler code
0004
Product ID
0004-0800_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
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
Tamiflu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE75 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0004-0800-072024-12-11C16284748780-11e7a6dab-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
0004-0800-082024-12-11C16284748780-11e7a6dab-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
0004-0800-852024-12-11C16284748780-11e7a6dab-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
0004-0800-072024-07-30C16284748780-11e7a6dab-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
0004-0800-082024-07-30C16284748780-11e7a6dab-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
0004-0800-852024-07-30C16284748780-11e7a6dab-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
0004-0800-07Tamiflu1 in 1 CARTONCAPSULE145
0004-0800-07Tamiflu10 in 1 BOTTLE, PLASTICCAPSULE1045
0004-0800-08Tamiflu10 in 1 BOTTLE, PLASTICCAPSULE1045
0004-0800-08Tamiflu1 in 1 CARTONCAPSULE145
0004-0800-85Tamiflu10 in 1 BLISTER PACKCAPSULE1045
0004-0800-85Tamiflu1 in 1 CARTONCAPSULE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0004-0800TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION [GENENTECH, INC.]44Current NDC, Legacy NDC, 6 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
728113oseltamivir phosphate 45 MG Oral CapsulePSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
312122oseltamivir phosphate 75 MG Oral CapsulePSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
728115Tamiflu 45 MG Oral CapsulePSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115700Tamiflu 6 MG in 1 mL Oral SuspensionPSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
261315Tamiflu 75 MG Oral CapsulePSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
728115oseltamivir 45 MG Oral Capsule [Tamiflu]SBD1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115700oseltamivir 6 MG/ML Oral Suspension [Tamiflu]SBD1948cafd-b5b3-4212-9d5d-8c293b1baad52
261315oseltamivir 75 MG Oral Capsule [Tamiflu]SBD1948cafd-b5b3-4212-9d5d-8c293b1baad52
728113oseltamivir 45 MG Oral CapsuleSCD1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115698oseltamivir 6 MG/ML Oral SuspensionSCD1948cafd-b5b3-4212-9d5d-8c293b1baad52
312122oseltamivir 75 MG Oral CapsuleSCD1948cafd-b5b3-4212-9d5d-8c293b1baad52
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
728115Tamiflu 45 MG Oral CapsuleSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115700Tamiflu 6 MG per 1 ML Oral SuspensionSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115700Tamiflu 6 MG/ML Oral SuspensionSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
261315Tamiflu 75 MG Oral CapsuleSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
312122oseltamivir phosphate 75 MG Oral CapsulePSN1b28c7c8-08c7-5ee9-e063-6394a90a72101
261315Tamiflu 75 MG Oral CapsulePSN1b28c7c8-08c7-5ee9-e063-6394a90a72101
261315oseltamivir 75 MG Oral Capsule [Tamiflu]SBD1b28c7c8-08c7-5ee9-e063-6394a90a72101
312122oseltamivir 75 MG Oral CapsuleSCD1b28c7c8-08c7-5ee9-e063-6394a90a72101
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1b28c7c8-08c7-5ee9-e063-6394a90a72101
261315Tamiflu 75 MG Oral CapsuleSY1b28c7c8-08c7-5ee9-e063-6394a90a72101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0004-0800-07000040800071 BOTTLE, PLASTIC in 1 CARTON (0004-0800-07) / 10 CAPSULE in 1 BOTTLE, PLASTIC2005-06-170000-00-00NoNoCurrent
0004-0800-08000040800081 BOTTLE, PLASTIC in 1 CARTON (0004-0800-08) / 10 CAPSULE in 1 BOTTLE, PLASTIC2005-06-172026-05-31NoNoCurrent
0004-0800-85000040800851 BLISTER PACK in 1 CARTON (0004-0800-85) / 10 CAPSULE in 1 BLISTER PACK1 blister pack1999-10-270000-00-00NoNoCurrent