Oseltamivir phosphate

Product NDC
68788-8831
11-digit product format
687888831
Labeler code
68788
Product ID
68788-8831_40312c99-5374-41fa-a687-c70d97445e24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208348
Marketing category
ANDA
Marketing start
2025-02-21
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
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 PHOSPHATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ
Rxcui312122

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
68788-8831-1Oseltamivir phosphate1 in 1 CARTONCAPSULE11
68788-8831-1Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8831-1EA - Each68788-88311716c247-87f3-4e80-acba-6f9060079e4a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8831OSELTAMIVIR PHOSPHATE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20250224_40312c99-5374-41fa-a687-c70d97445e24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN40312c99-5374-41fa-a687-c70d97445e241
312122oseltamivir 75 MG Oral CapsuleSCD40312c99-5374-41fa-a687-c70d97445e241
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY40312c99-5374-41fa-a687-c70d97445e241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8831-1687888831011 BLISTER PACK in 1 CARTON (68788-8831-1) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2025-02-21NoNoHistorical