FDA.reportPublic FDA data

Oseltamivir phosphate

Product NDC
72205-044
11-digit product format
722050044
Labeler code
72205
Product ID
72205-044_2944614f-d7c8-461e-8bcd-373feb20ea4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA212544
Marketing category
ANDA
Marketing start
2020-08-25
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oseltamivir phosphate
Listing expiration
2027-12-31

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
72205-044-11Oseltamivir phosphate1 in 1 CARTONCAPSULE13
72205-044-11Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-044-11EA - Each72205-044f45918e1-d1aa-4a51-9d41-53664e91bc4512020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-044OSELTAMIVIR PHOSPHATE CAPSULE [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20221206_c456f293-daf7-46b1-bffc-5ca234adbb70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN817f74ca-2b6d-4d29-8dd5-b96921a23b914
312122oseltamivir 75 MG Oral CapsuleSCD817f74ca-2b6d-4d29-8dd5-b96921a23b914
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY817f74ca-2b6d-4d29-8dd5-b96921a23b914
728109oseltamivir phosphate 30 MG Oral CapsulePSNc456f293-daf7-46b1-bffc-5ca234adbb703
728113oseltamivir phosphate 45 MG Oral CapsulePSNc456f293-daf7-46b1-bffc-5ca234adbb703
312122oseltamivir phosphate 75 MG Oral CapsulePSNc456f293-daf7-46b1-bffc-5ca234adbb703
728109oseltamivir 30 MG Oral CapsuleSCDc456f293-daf7-46b1-bffc-5ca234adbb703
728113oseltamivir 45 MG Oral CapsuleSCDc456f293-daf7-46b1-bffc-5ca234adbb703
312122oseltamivir 75 MG Oral CapsuleSCDc456f293-daf7-46b1-bffc-5ca234adbb703
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSYc456f293-daf7-46b1-bffc-5ca234adbb703
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYc456f293-daf7-46b1-bffc-5ca234adbb703
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYc456f293-daf7-46b1-bffc-5ca234adbb703
312122oseltamivir phosphate 75 MG Oral CapsulePSN37eb95bb-3142-4355-8057-4e7c784436411
312122oseltamivir phosphate 75 MG Oral CapsulePSNd4dd4b16-1f08-f837-e053-2995a90acd301
312122oseltamivir phosphate 75 MG Oral CapsulePSN1e193419-ece4-8d68-e063-6294a90a17901
312122oseltamivir 75 MG Oral CapsuleSCDd4dd4b16-1f08-f837-e053-2995a90acd301
312122oseltamivir 75 MG Oral CapsuleSCD1e193419-ece4-8d68-e063-6294a90a17901
312122oseltamivir 75 MG Oral CapsuleSCD37eb95bb-3142-4355-8057-4e7c784436411
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY37eb95bb-3142-4355-8057-4e7c784436411
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1e193419-ece4-8d68-e063-6294a90a17901
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYd4dd4b16-1f08-f837-e053-2995a90acd301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-044-11722050044111 BLISTER PACK in 1 CARTON (72205-044-11) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2020-08-250000-00-00NoNoCurrent