FDA.reportPublic FDA data

Oseltamivir Phosphate for Oral Suspension

Product NDC
42806-363
11-digit product format
428060363
Labeler code
42806
Product ID
42806-363_11d06cd6-d46d-492c-ac8c-5f4d6df6d9e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
EPIC PHARMA, LLC
Application
ANDA215538
Marketing category
ANDA
Marketing start
2022-08-02
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
42806-363-13Oseltamivir Phosphate for Oral Suspension1 in 1 CARTONPOWDER, FOR SUSPENSION12
42806-363-13Oseltamivir Phosphate for Oral Suspension60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-363OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION [EPIC PHARMA, LLC]2Current NDC, 2 package rows20231228_1b17fffc-5774-4b9b-8440-3a5295a34f89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN1b17fffc-5774-4b9b-8440-3a5295a34f892
1115698oseltamivir 6 MG/ML Oral SuspensionSCD1b17fffc-5774-4b9b-8440-3a5295a34f892
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY1b17fffc-5774-4b9b-8440-3a5295a34f892
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY1b17fffc-5774-4b9b-8440-3a5295a34f892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42806-363-13428060363131 BOTTLE, GLASS in 1 CARTON (42806-363-13) / 60 mL in 1 BOTTLE, GLASS2022-08-02NoNoCurrent