FDA.reportPublic FDA data

Oseltamivir phosphate

Product NDC
68180-676
11-digit product format
681800676
Labeler code
68180
Product ID
68180-676_d28b6190-f009-485f-905e-63f7a22fb68c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA208348
Marketing category
ANDA
Marketing start
2018-02-09
Substance
OSELTAMIVIR PHOSPHATE
Active strength
45 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
Oseltamivir phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ
Rxcui312122, 728109, 728113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-676-10Oseltamivir phosphate10 in 1 BOTTLECAPSULE1014
68180-676-11Oseltamivir phosphate1 in 1 CARTONCAPSULE114
68180-676-11Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-676OSELTAMIVIR PHOSPHATE CAPSULE [LUPIN PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 3 package rows20250206_7dd9f7f2-a887-454a-8d3e-761083b840db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN7dd9f7f2-a887-454a-8d3e-761083b840db14
728113oseltamivir phosphate 45 MG Oral CapsulePSN7dd9f7f2-a887-454a-8d3e-761083b840db14
312122oseltamivir phosphate 75 MG Oral CapsulePSN7dd9f7f2-a887-454a-8d3e-761083b840db14
728109oseltamivir 30 MG Oral CapsuleSCD7dd9f7f2-a887-454a-8d3e-761083b840db14
728113oseltamivir 45 MG Oral CapsuleSCD7dd9f7f2-a887-454a-8d3e-761083b840db14
312122oseltamivir 75 MG Oral CapsuleSCD7dd9f7f2-a887-454a-8d3e-761083b840db14
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY7dd9f7f2-a887-454a-8d3e-761083b840db14
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY7dd9f7f2-a887-454a-8d3e-761083b840db14
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY7dd9f7f2-a887-454a-8d3e-761083b840db14
728109oseltamivir phosphate 30 MG Oral CapsulePSN196c8dee-342b-4627-b060-39b99ed91a413
728113oseltamivir phosphate 45 MG Oral CapsulePSNe33583ad-90b9-4b61-9888-a974cbd5ede83
728113oseltamivir phosphate 45 MG Oral CapsulePSN196c8dee-342b-4627-b060-39b99ed91a413
728109oseltamivir 30 MG Oral CapsuleSCD196c8dee-342b-4627-b060-39b99ed91a413
728113oseltamivir 45 MG Oral CapsuleSCD196c8dee-342b-4627-b060-39b99ed91a413
728113oseltamivir 45 MG Oral CapsuleSCDe33583ad-90b9-4b61-9888-a974cbd5ede83
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY196c8dee-342b-4627-b060-39b99ed91a413
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYe33583ad-90b9-4b61-9888-a974cbd5ede83
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY196c8dee-342b-4627-b060-39b99ed91a413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-676-106818006761010 CAPSULE in 1 BOTTLE (68180-676-10) 10 capsule2018-02-090000-00-00NoNoCurrent
68180-676-11681800676111 BLISTER PACK in 1 CARTON (68180-676-11) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2018-02-090000-00-00NoNoCurrent