Oseltamivir Phosphate

Product NDC
42291-567
11-digit product format
422910567
Labeler code
42291
Product ID
42291-567_48710df3-756b-836d-e063-6394a90a1bd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
AvKARE
Application
ANDA210186
Marketing category
ANDA
Marketing start
2019-08-26
Substance
OSELTAMIVIR PHOSPHATE
Active strength
6 mg/mL
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oseltamivir Phosphate
Listing expiration
2027-12-31

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
42291-567-60Oseltamivir Phosphate60 mL in 1 BOTTLE, GLASSFOR SUSPENSION609
42291-567-60Oseltamivir Phosphate1 in 1 CARTONFOR SUSPENSION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-567-60ML - Milliliter42291-56776677d2c-368e-4d91-9418-65e7e9b61cb912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-567OSELTAMIVIR PHOSPHATE FOR SUSPENSION [AVKARE]8Current NDC, Legacy NDC, 2 package rows20230325_7d8ce967-8037-9fd5-e053-2991aa0a015f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN7d8ce967-8037-9fd5-e053-2991aa0a015f9
1115698oseltamivir 6 MG/ML Oral SuspensionSCD7d8ce967-8037-9fd5-e053-2991aa0a015f9
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY7d8ce967-8037-9fd5-e053-2991aa0a015f9
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY7d8ce967-8037-9fd5-e053-2991aa0a015f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-567-60422910567601 BOTTLE, GLASS in 1 CARTON (42291-567-60) / 60 mL in 1 BOTTLE, GLASS2019-08-260000-00-00NoNoCurrent