Oseltamivir Phosphate

Product NDC
64380-879
11-digit product format
643800879
Labeler code
64380
Product ID
64380-879_77e8e587-76ff-4587-862a-a700565c0bc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA211894
Marketing category
ANDA
Marketing start
2022-10-24
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
64380-879-75Oseltamivir Phosphate1 in 1 CARTONPOWDER, FOR SUSPENSION17
64380-879-75Oseltamivir Phosphate60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-879-75ML - Milliliter64380-87960fdcaaa-3d3c-46fd-ac5e-bf4adc3de29812022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-879OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [STRIDES PHARMA SCIENCE LIMITED]7Current NDC, Legacy NDC, 2 package rows20221024_39255500-0ffd-4d72-abe8-257570b543e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN39255500-0ffd-4d72-abe8-257570b543e77
1115698oseltamivir 6 MG/ML Oral SuspensionSCD39255500-0ffd-4d72-abe8-257570b543e77
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY39255500-0ffd-4d72-abe8-257570b543e77
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY39255500-0ffd-4d72-abe8-257570b543e77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64380-879-75643800879751 BOTTLE, GLASS in 1 CARTON (64380-879-75) / 60 mL in 1 BOTTLE, GLASS2022-10-240000-00-00NoNoCurrent