FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
0093-8180
11-digit product format
000938180
Labeler code
0093
Product ID
0093-8180_f8f3e33e-61de-4fe8-9a9b-11404ab66ded
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA211125
Marketing category
ANDA
Marketing start
2019-07-10
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-8180-64Oseltamivir Phosphate1 in 1 CARTONPOWDER, FOR SUSPENSION15
0093-8180-64Oseltamivir Phosphate60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8180-64ML - Milliliter0093-8180c1efc242-a76b-4bba-963f-63ab30d23cf812019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8180OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA, INC.]4Current NDC, Legacy NDC, 2 package rows20221020_3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN73d7fa5a-8304-44b7-9456-58926a265d816
1115698oseltamivir 6 MG/ML Oral SuspensionSCD73d7fa5a-8304-44b7-9456-58926a265d816
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY73d7fa5a-8304-44b7-9456-58926a265d816
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY73d7fa5a-8304-44b7-9456-58926a265d816
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b5
1115698oseltamivir 6 MG/ML Oral SuspensionSCD3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b5
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b5
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-8180-64000938180641 BOTTLE in 1 CARTON (0093-8180-64) / 60 mL in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent