Oseltamivir Phosphate

Product NDC
82804-018
11-digit product format
828040018
Labeler code
82804
Product ID
82804-018_8e81aaa7-7c40-4b05-b19a-cc70edd1d9f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209438
Marketing category
ANDA
Marketing start
2018-02-23
Substance
OSELTAMIVIR PHOSPHATE
Active strength
30 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 PHOSPHATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ
Rxcui728109

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
82804-018-10Oseltamivir Phosphate10 in 1 CARTONCAPSULE101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-018-10EA - Each82804-018ca98b75a-c910-49bd-afcb-b61f65e20e5712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-018OSELTAMIVIR PHOSPHATE CAPSULE [PROFICIENT RX LP]1Current NDC, 1 package rows20231202_8e81aaa7-7c40-4b05-b19a-cc70edd1d9f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN8e81aaa7-7c40-4b05-b19a-cc70edd1d9f91
728109oseltamivir 30 MG Oral CapsuleSCD8e81aaa7-7c40-4b05-b19a-cc70edd1d9f91
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY8e81aaa7-7c40-4b05-b19a-cc70edd1d9f91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-018-108280400181010 CAPSULE in 1 CARTON (82804-018-10) 10 capsule2023-11-17NoNoCurrent