Oseltamivir phosphate

Product NDC
31722-108
11-digit product format
317220108
Labeler code
31722
Product ID
31722-108_e073e3ca-04f9-a4ba-e053-2a95a90af358
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA209590
Marketing category
ANDA
Marketing start
2022-03-28
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
31722-108-60Oseltamivir phosphate360 mL in 1 BOTTLEPOWDER, FOR SUSPENSION3601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-108OSELTAMIVIR PHOSPHATE (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 1 package rows20220603_5c959361-8f08-4c65-968f-404a44422133.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN5c959361-8f08-4c65-968f-404a444221331
1115698oseltamivir 6 MG/ML Oral SuspensionSCD5c959361-8f08-4c65-968f-404a444221331
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY5c959361-8f08-4c65-968f-404a444221331
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY5c959361-8f08-4c65-968f-404a444221331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-108-6031722010860360 mL in 1 BOTTLE (31722-108-60) 360 ml2022-03-280000-00-00NoNoCurrent