Oseltamivir phosphate

Product NDC
68788-8309
11-digit product format
687888309
Labeler code
68788
Product ID
68788-8309_61d2732e-67c7-485c-bc53-b31cfbc6b2b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA212544
Marketing category
ANDA
Marketing start
2022-12-20
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
68788-8309-1Oseltamivir phosphate1 in 1 CARTONCAPSULE14
68788-8309-1Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8309-1EA - Each68788-8309379990f2-aa16-4c33-ba4e-b974cd7f82a312023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8309OSELTAMIVIR PHOSPHATE CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240726_817f74ca-2b6d-4d29-8dd5-b96921a23b91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN817f74ca-2b6d-4d29-8dd5-b96921a23b914
312122oseltamivir 75 MG Oral CapsuleSCD817f74ca-2b6d-4d29-8dd5-b96921a23b914
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY817f74ca-2b6d-4d29-8dd5-b96921a23b914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8309-1687888309011 BLISTER PACK in 1 CARTON (68788-8309-1) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2022-12-200000-00-00NoNoCurrent