FDA.reportPublic FDA data

Oseltamivir phosphate

Product NDC
68180-677
11-digit product format
681800677
Labeler code
68180
Product ID
68180-677_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
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
Oseltamivir phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ
Rxcui312122, 728109, 728113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-677-10Oseltamivir phosphate10 in 1 BOTTLECAPSULE1014
68180-677-11Oseltamivir phosphate1 in 1 CARTONCAPSULE114
68180-677-11Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-677-11EA - Each68180-677c583c3e7-04a6-4a74-ad56-2beace0beb8212018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-677OSELTAMIVIR 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
312122oseltamivir phosphate 75 MG Oral CapsulePSNcd0236c6-317c-47b1-9185-3253dba4bb374
312122oseltamivir phosphate 75 MG Oral CapsulePSNad765459-e0d2-418e-8bae-8f6d16dfc1d84
312122oseltamivir 75 MG Oral CapsuleSCDcd0236c6-317c-47b1-9185-3253dba4bb374
312122oseltamivir 75 MG Oral CapsuleSCDad765459-e0d2-418e-8bae-8f6d16dfc1d84
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYcd0236c6-317c-47b1-9185-3253dba4bb374
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYad765459-e0d2-418e-8bae-8f6d16dfc1d84
312122oseltamivir phosphate 75 MG Oral CapsulePSN40312c99-5374-41fa-a687-c70d97445e241
312122oseltamivir phosphate 75 MG Oral CapsulePSN1f3ed814-7243-6581-e063-6394a90a40851
312122oseltamivir 75 MG Oral CapsuleSCD40312c99-5374-41fa-a687-c70d97445e241
312122oseltamivir 75 MG Oral CapsuleSCD1f3ed814-7243-6581-e063-6394a90a40851
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY40312c99-5374-41fa-a687-c70d97445e241
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1f3ed814-7243-6581-e063-6394a90a40851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-677-106818006771010 CAPSULE in 1 BOTTLE (68180-677-10) 10 capsule2018-02-090000-00-00NoNoCurrent
68180-677-11681800677111 BLISTER PACK in 1 CARTON (68180-677-11) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2018-02-090000-00-00NoNoCurrent