FDA.reportPublic FDA data

OSELTAMIVIR PHOSPHATE

Product NDC
70771-1711
11-digit product format
707711711
Labeler code
70771
Product ID
70771-1711_1e8d55a0-7d87-4135-886c-d0e6591d9917
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA208578
Marketing category
ANDA
Marketing start
2017-02-24
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
70771-1711-2OSELTAMIVIR PHOSPHATE1 in 1 CARTONCAPSULE13
70771-1711-2OSELTAMIVIR PHOSPHATE10 in 1 BLISTER PACKCAPSULE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1711OSELTAMIVIR PHOSPHATE CAPSULE [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 2 package rows20241206_58118069-cb24-4fa3-92d7-cabdc1b027f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN58118069-cb24-4fa3-92d7-cabdc1b027f23
728113oseltamivir phosphate 45 MG Oral CapsulePSN58118069-cb24-4fa3-92d7-cabdc1b027f23
312122oseltamivir phosphate 75 MG Oral CapsulePSN58118069-cb24-4fa3-92d7-cabdc1b027f23
728109oseltamivir 30 MG Oral CapsuleSCD58118069-cb24-4fa3-92d7-cabdc1b027f23
728113oseltamivir 45 MG Oral CapsuleSCD58118069-cb24-4fa3-92d7-cabdc1b027f23
312122oseltamivir 75 MG Oral CapsuleSCD58118069-cb24-4fa3-92d7-cabdc1b027f23
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY58118069-cb24-4fa3-92d7-cabdc1b027f23
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY58118069-cb24-4fa3-92d7-cabdc1b027f23
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY58118069-cb24-4fa3-92d7-cabdc1b027f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1711-2707711711021 BLISTER PACK in 1 CARTON (70771-1711-2) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2017-02-240000-00-00NoNoCurrent