FDA.reportPublic FDA data

Oseltamivir Phosphate for Oral Suspension

Product NDC
47781-384
11-digit product format
477810384
Labeler code
47781
Product ID
47781-384_bc6ab861-892d-407f-7187-e7a9e31bd593
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA208823
Marketing category
ANDA
Marketing start
2017-11-01
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 for Oral Suspension
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-384-26Oseltamivir Phosphate for Oral Suspension1 in 1 CARTONPOWDER, FOR SUSPENSION113
47781-384-26Oseltamivir Phosphate for Oral Suspension60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-384-26ML - Milliliter47781-3842edeff7c-10ae-401e-a357-ef5f1e52d7bf12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-384OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION [ALVOGEN INC.]13Current NDC, Legacy NDC, 2 package rows20250501_82df3237-636b-7bf9-3ba0-2b476e74bf4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN82df3237-636b-7bf9-3ba0-2b476e74bf4c13
1115698oseltamivir 6 MG/ML Oral SuspensionSCD82df3237-636b-7bf9-3ba0-2b476e74bf4c13
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY82df3237-636b-7bf9-3ba0-2b476e74bf4c13
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY82df3237-636b-7bf9-3ba0-2b476e74bf4c13
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN27745acb-69a3-a1af-e063-6394a90ab10f1
1115698oseltamivir 6 MG/ML Oral SuspensionSCD27745acb-69a3-a1af-e063-6394a90ab10f1
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY27745acb-69a3-a1af-e063-6394a90ab10f1
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY27745acb-69a3-a1af-e063-6394a90ab10f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-384-26477810384261 BOTTLE, GLASS in 1 CARTON (47781-384-26) / 60 mL in 1 BOTTLE, GLASS2017-11-010000-00-00NoNoCurrent