OSELTAMIVIR PHOSPHATE

Product NDC
69097-904
11-digit product format
690970904
Labeler code
69097
Product ID
69097-904_4e8c50c0-4026-4047-ac0b-6d8bbb56f923
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OSELTAMIVIR PHOSPHATE
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Cipla USA, Inc
Application
ANDA212858
Marketing category
ANDA
Marketing start
2023-01-16
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
69097-904-43OSELTAMIVIR PHOSPHATE60 mL in 1 BOTTLEFOR SUSPENSION603
69097-904-43OSELTAMIVIR PHOSPHATE1 in 1 CARTONFOR SUSPENSION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-904-43ML - Milliliter69097-9044bbd0b1f-6996-4b64-9d29-02452e19f10412023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-904OSELTAMIVIR PHOSPHATE FOR SUSPENSION [CIPLA USA, INC]3Current NDC, 2 package rows20230504_7d04f367-8f62-4f63-bac9-717d14f555a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN7d04f367-8f62-4f63-bac9-717d14f555a53
1115698oseltamivir 6 MG/ML Oral SuspensionSCD7d04f367-8f62-4f63-bac9-717d14f555a53
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY7d04f367-8f62-4f63-bac9-717d14f555a53
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY7d04f367-8f62-4f63-bac9-717d14f555a53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-904-43690970904431 BOTTLE in 1 CARTON (69097-904-43) / 60 mL in 1 BOTTLE1 bottle2023-01-16NoNoHistorical