FDA.reportPublic FDA data

Oseltamivir phosphate

Product NDC
68788-8123
11-digit product format
687888123
Labeler code
68788
Product ID
68788-8123_cb62d282-af91-47d6-b128-4ea9c11def51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA212784
Marketing category
ANDA
Marketing start
2022-01-10
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
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
68788-8123-6Oseltamivir phosphate1 in 1 POUCHFOR SUSPENSION14
68788-8123-6Oseltamivir phosphate1 in 1 CARTONFOR SUSPENSION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8123-6ML - Milliliter68788-8123f008348d-95d7-4e61-baf9-94a595ffe87912022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8123OSELTAMIVIR PHOSPHATE FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240726_16fcbcb4-609c-4d4e-a134-013823207dc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN16fcbcb4-609c-4d4e-a134-013823207dc74
1115698oseltamivir 6 MG/ML Oral SuspensionSCD16fcbcb4-609c-4d4e-a134-013823207dc74
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY16fcbcb4-609c-4d4e-a134-013823207dc74
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY16fcbcb4-609c-4d4e-a134-013823207dc74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8123-6687888123061 POUCH in 1 CARTON (68788-8123-6) / 1 BOTTLE in 1 POUCH / 60 mL in 1 BOTTLE1 pouch2022-01-100000-00-00NoNoCurrent