Oseltamivir Phosphate

Product NDC
0527-4591
11-digit product format
005274591
Labeler code
0527
Product ID
0527-4591_00e310fb-2460-a1bf-e063-6394a90a2457
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA212739
Marketing category
ANDA
Marketing start
2023-05-15
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
Rxcui312122, 728109, 728113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-4591-13Oseltamivir Phosphate1 in 1 CARTONCAPSULE11
0527-4591-13Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-4591OSELTAMIVIR PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]1Current NDC, 2 package rows20230720_00e2e995-6296-b544-e063-6294a90a8345.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN2fd237e8-7ac9-f473-e063-6294a90aadfc3
728109oseltamivir 30 MG Oral CapsuleSCD2fd237e8-7ac9-f473-e063-6294a90aadfc3
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY2fd237e8-7ac9-f473-e063-6294a90aadfc3
728109oseltamivir phosphate 30 MG Oral CapsulePSN00e2e995-6296-b544-e063-6294a90a83451
728113oseltamivir phosphate 45 MG Oral CapsulePSN00e2e995-6296-b544-e063-6294a90a83451
312122oseltamivir phosphate 75 MG Oral CapsulePSN00e2e995-6296-b544-e063-6294a90a83451
728109oseltamivir 30 MG Oral CapsuleSCD00e2e995-6296-b544-e063-6294a90a83451
728113oseltamivir 45 MG Oral CapsuleSCD00e2e995-6296-b544-e063-6294a90a83451
312122oseltamivir 75 MG Oral CapsuleSCD00e2e995-6296-b544-e063-6294a90a83451
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY00e2e995-6296-b544-e063-6294a90a83451
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY00e2e995-6296-b544-e063-6294a90a83451
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY00e2e995-6296-b544-e063-6294a90a83451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0527-4591-13005274591131 BLISTER PACK in 1 CARTON (0527-4591-13) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2023-05-15NoNoCurrent