FDA.reportPublic FDA data

oseltamivir phosphate

Product NDC
33342-257
11-digit product format
333420257
Labeler code
33342
Product ID
33342-257_e6722163-0760-4653-bab9-1bb1a603e935
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA207211
Marketing category
ANDA
Marketing start
2017-09-21
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
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-257-66oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE107
33342-257-66oseltamivir phosphate01 in 1 CARTONCAPSULE017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-257OSELTAMAVIR PHOSPHATE CAPSULE [MACLEODS PHARMACEUTICALS LIMITED]6Current NDC, Legacy NDC, 2 package rows20220906_e9307620-36bd-46c2-a8b2-027d3fba87ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSNe9307620-36bd-46c2-a8b2-027d3fba87ba7
728113oseltamivir phosphate 45 MG Oral CapsulePSNe9307620-36bd-46c2-a8b2-027d3fba87ba7
312122oseltamivir phosphate 75 MG Oral CapsulePSNe9307620-36bd-46c2-a8b2-027d3fba87ba7
728109oseltamivir 30 MG Oral CapsuleSCDe9307620-36bd-46c2-a8b2-027d3fba87ba7
728113oseltamivir 45 MG Oral CapsuleSCDe9307620-36bd-46c2-a8b2-027d3fba87ba7
312122oseltamivir 75 MG Oral CapsuleSCDe9307620-36bd-46c2-a8b2-027d3fba87ba7
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSYe9307620-36bd-46c2-a8b2-027d3fba87ba7
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYe9307620-36bd-46c2-a8b2-027d3fba87ba7
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYe9307620-36bd-46c2-a8b2-027d3fba87ba7
728113oseltamivir phosphate 45 MG Oral CapsulePSN28ddaeb7-5903-4b59-e063-6294a90a2bcd1
728113oseltamivir phosphate 45 MG Oral CapsulePSNccdb124d-fd56-409a-8615-ae0f675cd8e41
728113oseltamivir 45 MG Oral CapsuleSCD28ddaeb7-5903-4b59-e063-6294a90a2bcd1
728113oseltamivir 45 MG Oral CapsuleSCDccdb124d-fd56-409a-8615-ae0f675cd8e41
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY28ddaeb7-5903-4b59-e063-6294a90a2bcd1
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYccdb124d-fd56-409a-8615-ae0f675cd8e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-257-66333420257661 BLISTER PACK in 1 CARTON (33342-257-66) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2017-09-210000-00-00NoNoCurrent