FDA.reportPublic FDA data

Oseltamivir phosphate

Product NDC
72205-042
11-digit product format
722050042
Labeler code
72205
Product ID
72205-042_2944614f-d7c8-461e-8bcd-373feb20ea4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA212544
Marketing category
ANDA
Marketing start
2020-08-25
Substance
OSELTAMIVIR PHOSPHATE
Active strength
30 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oseltamivir phosphate
Listing expiration
2027-12-31

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
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-042-11Oseltamivir phosphate1 in 1 CARTONCAPSULE13
72205-042-11Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-042-11EA - Each72205-042ec58d359-6b09-4030-b92a-f5e857587ff912020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-042OSELTAMIVIR PHOSPHATE CAPSULE [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20221206_c456f293-daf7-46b1-bffc-5ca234adbb70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSNc456f293-daf7-46b1-bffc-5ca234adbb703
728113oseltamivir phosphate 45 MG Oral CapsulePSNc456f293-daf7-46b1-bffc-5ca234adbb703
312122oseltamivir phosphate 75 MG Oral CapsulePSNc456f293-daf7-46b1-bffc-5ca234adbb703
728109oseltamivir 30 MG Oral CapsuleSCDc456f293-daf7-46b1-bffc-5ca234adbb703
728113oseltamivir 45 MG Oral CapsuleSCDc456f293-daf7-46b1-bffc-5ca234adbb703
312122oseltamivir 75 MG Oral CapsuleSCDc456f293-daf7-46b1-bffc-5ca234adbb703
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSYc456f293-daf7-46b1-bffc-5ca234adbb703
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYc456f293-daf7-46b1-bffc-5ca234adbb703
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYc456f293-daf7-46b1-bffc-5ca234adbb703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-042-11722050042111 BLISTER PACK in 1 CARTON (72205-042-11) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2020-08-250000-00-00NoNoCurrent