FDA.reportPublic FDA data

oseltamivir phosphate

Product NDC
33342-258
11-digit product format
333420258
Labeler code
33342
Product ID
33342-258_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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-258-66oseltamivir phosphate01 in 1 CARTONCAPSULE017
33342-258-66oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-258-66EA - Each33342-25839d993bc-b44b-4d0b-932e-b16748804c4c12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-258OSELTAMAVIR 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
312122oseltamivir phosphate 75 MG Oral CapsulePSN09e119eb-a8fa-4635-96a7-1b134593cdca5
312122oseltamivir phosphate 75 MG Oral CapsulePSN5bb70d91-1beb-4183-902e-bdcf907be5c35
312122oseltamivir phosphate 75 MG Oral CapsulePSN80511c6f-88b9-62d3-e053-2991aa0ab9365
312122oseltamivir 75 MG Oral CapsuleSCD80511c6f-88b9-62d3-e053-2991aa0ab9365
312122oseltamivir 75 MG Oral CapsuleSCD5bb70d91-1beb-4183-902e-bdcf907be5c35
312122oseltamivir 75 MG Oral CapsuleSCD09e119eb-a8fa-4635-96a7-1b134593cdca5
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY80511c6f-88b9-62d3-e053-2991aa0ab9365
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY09e119eb-a8fa-4635-96a7-1b134593cdca5
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY5bb70d91-1beb-4183-902e-bdcf907be5c35
312122oseltamivir phosphate 75 MG Oral CapsulePSN42a9278f-cc69-4615-8324-74af1472b64e2
312122oseltamivir 75 MG Oral CapsuleSCD42a9278f-cc69-4615-8324-74af1472b64e2
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY42a9278f-cc69-4615-8324-74af1472b64e2
312122oseltamivir phosphate 75 MG Oral CapsulePSN1ebe16f9-09e0-799c-e063-6394a90a76771
312122oseltamivir 75 MG Oral CapsuleSCD1ebe16f9-09e0-799c-e063-6394a90a76771
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1ebe16f9-09e0-799c-e063-6394a90a76771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-258-66333420258661 BLISTER PACK in 1 CARTON (33342-258-66) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2017-09-210000-00-00NoNoCurrent