Oseltamivir Phosphate

Product NDC
68788-8122
11-digit product format
687888122
Labeler code
68788
Product ID
68788-8122_9d39df7d-43af-4692-aeb4-b75533408f9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209421
Marketing category
ANDA
Marketing start
2022-01-10
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
68788-8122-1Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8122-1EA - Each68788-81226e512ad1-8291-4051-a649-abfe05533c0f12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8122OSELTAMIVIR PHOSPHATE CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20240726_89a3539b-a067-4073-b7a0-d04e7f130396.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN89a3539b-a067-4073-b7a0-d04e7f1303964
312122oseltamivir 75 MG Oral CapsuleSCD89a3539b-a067-4073-b7a0-d04e7f1303964
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY89a3539b-a067-4073-b7a0-d04e7f1303964

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8122-16878881220110 CAPSULE in 1 BLISTER PACK (68788-8122-1) 10 capsule2022-01-100000-00-00NoNoCurrent