FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
64380-799
11-digit product format
643800799
Labeler code
64380
Product ID
64380-799_aa0e2642-b771-4a8d-b790-cac43f40f956
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA209421
Marketing category
ANDA
Marketing start
2018-10-05
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, 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
64380-799-01Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE108
64380-799-06Oseltamivir Phosphate100 in 1 BOTTLECAPSULE1008
64380-799-07Oseltamivir Phosphate500 in 1 BOTTLECAPSULE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-799-01EA - Each64380-79979a0faea-3760-4fc5-b884-4b71d676273212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-799OSELTAMIVIR PHOSPHATE CAPSULE [STRIDES PHARMA SCIENCE LIMITED]8Current NDC, Legacy NDC, 3 package rows20221213_f26154bd-374c-44a8-983a-b2724a591653.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSNf26154bd-374c-44a8-983a-b2724a5916538
728113oseltamivir phosphate 45 MG Oral CapsulePSNf26154bd-374c-44a8-983a-b2724a5916538
312122oseltamivir phosphate 75 MG Oral CapsulePSNf26154bd-374c-44a8-983a-b2724a5916538
728109oseltamivir 30 MG Oral CapsuleSCDf26154bd-374c-44a8-983a-b2724a5916538
728113oseltamivir 45 MG Oral CapsuleSCDf26154bd-374c-44a8-983a-b2724a5916538
312122oseltamivir 75 MG Oral CapsuleSCDf26154bd-374c-44a8-983a-b2724a5916538
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSYf26154bd-374c-44a8-983a-b2724a5916538
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYf26154bd-374c-44a8-983a-b2724a5916538
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYf26154bd-374c-44a8-983a-b2724a5916538
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
312122oseltamivir phosphate 75 MG Oral CapsulePSN91eadf0b-5f04-4f5d-b095-02c5736a36473
312122oseltamivir 75 MG Oral CapsuleSCD91eadf0b-5f04-4f5d-b095-02c5736a36473
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY91eadf0b-5f04-4f5d-b095-02c5736a36473
312122oseltamivir phosphate 75 MG Oral CapsulePSNde553d49-38c3-4fad-8582-d4d27c3c26b12
312122oseltamivir phosphate 75 MG Oral CapsulePSNcffe01a3-cd42-3ff2-e053-2995a90adc022
312122oseltamivir 75 MG Oral CapsuleSCDde553d49-38c3-4fad-8582-d4d27c3c26b12
312122oseltamivir 75 MG Oral CapsuleSCDcffe01a3-cd42-3ff2-e053-2995a90adc022
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYde553d49-38c3-4fad-8582-d4d27c3c26b12
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYcffe01a3-cd42-3ff2-e053-2995a90adc022
728109oseltamivir phosphate 30 MG Oral CapsulePSN92726a00-4237-49fd-9e29-5d4f5f9998741
728113oseltamivir phosphate 45 MG Oral CapsulePSN92726a00-4237-49fd-9e29-5d4f5f9998741
312122oseltamivir phosphate 75 MG Oral CapsulePSN9aa12239-dbf3-4655-a1c4-e9cad4876c181
312122oseltamivir phosphate 75 MG Oral CapsulePSN1eba68d2-8b3b-802b-e063-6294a90a38521
312122oseltamivir phosphate 75 MG Oral CapsulePSN1e19bb83-0497-1c87-e063-6394a90aafd41
312122oseltamivir phosphate 75 MG Oral CapsulePSN78f85d27-9935-4775-b8d7-275e11429b761
312122oseltamivir phosphate 75 MG Oral CapsulePSN92726a00-4237-49fd-9e29-5d4f5f9998741
728109oseltamivir 30 MG Oral CapsuleSCD92726a00-4237-49fd-9e29-5d4f5f9998741
728113oseltamivir 45 MG Oral CapsuleSCD92726a00-4237-49fd-9e29-5d4f5f9998741
312122oseltamivir 75 MG Oral CapsuleSCD92726a00-4237-49fd-9e29-5d4f5f9998741
312122oseltamivir 75 MG Oral CapsuleSCD1e19bb83-0497-1c87-e063-6394a90aafd41
312122oseltamivir 75 MG Oral CapsuleSCD1eba68d2-8b3b-802b-e063-6294a90a38521
312122oseltamivir 75 MG Oral CapsuleSCD78f85d27-9935-4775-b8d7-275e11429b761
312122oseltamivir 75 MG Oral CapsuleSCD9aa12239-dbf3-4655-a1c4-e9cad4876c181
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY92726a00-4237-49fd-9e29-5d4f5f9998741
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY92726a00-4237-49fd-9e29-5d4f5f9998741
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY78f85d27-9935-4775-b8d7-275e11429b761
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1eba68d2-8b3b-802b-e063-6294a90a38521
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY9aa12239-dbf3-4655-a1c4-e9cad4876c181
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY92726a00-4237-49fd-9e29-5d4f5f9998741
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1e19bb83-0497-1c87-e063-6394a90aafd41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-799-016438007990110 CAPSULE in 1 BLISTER PACK (64380-799-01) 10 capsule2018-10-050000-00-00NoNoCurrent
64380-799-0664380079906100 CAPSULE in 1 BOTTLE (64380-799-06) 100 capsule2021-11-300000-00-00NoNoCurrent
64380-799-0764380079907500 CAPSULE in 1 BOTTLE (64380-799-07) 500 capsule2021-10-010000-00-00NoNoCurrent