FDA.reportPublic FDA data

OSELTAMIVIR PHOSPHATE

Product NDC
70710-1010
11-digit product format
707101010
Labeler code
70710
Product ID
70710-1010_31f89cf8-7032-4ada-ac9a-471122dad992
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA208578
Marketing category
ANDA
Marketing start
2017-02-24
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
70710-1010-2OSELTAMIVIR PHOSPHATE10 in 1 BLISTER PACKCAPSULE1010
70710-1010-2OSELTAMIVIR PHOSPHATE1 in 1 CARTONCAPSULE110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1010OSELTAMIVIR PHOSPHATE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20221229_0e666061-1bfd-48cd-896b-ded8298a1847.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN0e666061-1bfd-48cd-896b-ded8298a184710
728113oseltamivir phosphate 45 MG Oral CapsulePSN0e666061-1bfd-48cd-896b-ded8298a184710
312122oseltamivir phosphate 75 MG Oral CapsulePSN0e666061-1bfd-48cd-896b-ded8298a184710
728109oseltamivir 30 MG Oral CapsuleSCD0e666061-1bfd-48cd-896b-ded8298a184710
728113oseltamivir 45 MG Oral CapsuleSCD0e666061-1bfd-48cd-896b-ded8298a184710
312122oseltamivir 75 MG Oral CapsuleSCD0e666061-1bfd-48cd-896b-ded8298a184710
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY0e666061-1bfd-48cd-896b-ded8298a184710
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY0e666061-1bfd-48cd-896b-ded8298a184710
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY0e666061-1bfd-48cd-896b-ded8298a184710
728113oseltamivir phosphate 45 MG Oral CapsulePSN82fc6ef1-cc49-4f65-a91d-04a8572689cb8
312122oseltamivir phosphate 75 MG Oral CapsulePSN82fc6ef1-cc49-4f65-a91d-04a8572689cb8
728113oseltamivir 45 MG Oral CapsuleSCD82fc6ef1-cc49-4f65-a91d-04a8572689cb8
312122oseltamivir 75 MG Oral CapsuleSCD82fc6ef1-cc49-4f65-a91d-04a8572689cb8
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY82fc6ef1-cc49-4f65-a91d-04a8572689cb8
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY82fc6ef1-cc49-4f65-a91d-04a8572689cb8
312122oseltamivir phosphate 75 MG Oral CapsulePSN45f9c122-a845-4871-aa7f-11fbc86033065
312122oseltamivir 75 MG Oral CapsuleSCD45f9c122-a845-4871-aa7f-11fbc86033065
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY45f9c122-a845-4871-aa7f-11fbc86033065
312122oseltamivir phosphate 75 MG Oral CapsulePSN2fbd0c56-82bf-f0fa-e063-6294a90a9f2f3
312122oseltamivir 75 MG Oral CapsuleSCD2fbd0c56-82bf-f0fa-e063-6294a90a9f2f3
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY2fbd0c56-82bf-f0fa-e063-6294a90a9f2f3
312122oseltamivir phosphate 75 MG Oral CapsulePSN1f33ede5-73f8-0304-e063-6294a90a6dd51
312122oseltamivir phosphate 75 MG Oral CapsulePSN9dac3ba2-b667-4081-9395-8db45d38ceac1
312122oseltamivir 75 MG Oral CapsuleSCD1f33ede5-73f8-0304-e063-6294a90a6dd51
312122oseltamivir 75 MG Oral CapsuleSCD9dac3ba2-b667-4081-9395-8db45d38ceac1
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1f33ede5-73f8-0304-e063-6294a90a6dd51
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY9dac3ba2-b667-4081-9395-8db45d38ceac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1010-2707101010021 BLISTER PACK in 1 CARTON (70710-1010-2) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2017-02-240000-00-00NoNoCurrent