FDA.reportPublic FDA data

OSELTAMIVIR PHOSPHATE

Product NDC
70710-1165
11-digit product format
707101165
Labeler code
70710
Product ID
70710-1165_73c48039-409b-4769-ab13-fc929efe0e28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA209113
Marketing category
ANDA
Marketing start
2017-09-14
Substance
OSELTAMIVIR PHOSPHATE
Active strength
6 mg/mL
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 PHOSPHATE6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ
Rxcui1115698

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
70710-1165-6OSELTAMIVIR PHOSPHATE1 in 1 CARTONFOR SUSPENSION18
70710-1165-6OSELTAMIVIR PHOSPHATE60 mL in 1 BOTTLEFOR SUSPENSION608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1165-6ML - Milliliter70710-11650e3a3266-469e-433b-b994-33c6227a273f12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1165OSELTAMIVIR PHOSPHATE FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20230317_432d9e7b-9cb2-4b7d-9fb2-015449096757.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN432d9e7b-9cb2-4b7d-9fb2-0154490967578
1115698oseltamivir 6 MG/ML Oral SuspensionSCD432d9e7b-9cb2-4b7d-9fb2-0154490967578
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY432d9e7b-9cb2-4b7d-9fb2-0154490967578
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY432d9e7b-9cb2-4b7d-9fb2-0154490967578
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSNb1abef84-d074-4872-9193-48a52cbabbd66
1115698oseltamivir 6 MG/ML Oral SuspensionSCDb1abef84-d074-4872-9193-48a52cbabbd66
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSYb1abef84-d074-4872-9193-48a52cbabbd66
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSYb1abef84-d074-4872-9193-48a52cbabbd66
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN9a486c32-1cc8-465c-bf57-43e71b09446e4
1115698oseltamivir 6 MG/ML Oral SuspensionSCD9a486c32-1cc8-465c-bf57-43e71b09446e4
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY9a486c32-1cc8-465c-bf57-43e71b09446e4
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY9a486c32-1cc8-465c-bf57-43e71b09446e4
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN80b25513-4ee7-7f07-e053-2991aa0ab1063
1115698oseltamivir 6 MG/ML Oral SuspensionSCD80b25513-4ee7-7f07-e053-2991aa0ab1063
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY80b25513-4ee7-7f07-e053-2991aa0ab1063
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY80b25513-4ee7-7f07-e053-2991aa0ab1063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1165-6707101165061 BOTTLE in 1 CARTON (70710-1165-6) / 60 mL in 1 BOTTLE1 bottle2017-09-140000-00-00NoNoCurrent