FDA.reportPublic FDA data

OSELTAMIVIR PHOSPHATE

Product NDC
59651-597
11-digit product format
596510597
Labeler code
59651
Product ID
59651-597_5806ee9b-f0ce-4ff1-929c-8df9f6337727
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OSELTAMIVIR PHOSPHATE
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218131
Marketing category
ANDA
Marketing start
2024-05-10
Substance
OSELTAMIVIR PHOSPHATE
Active strength
6 mg/mL
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 PHOSPHATE6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ
Rxcui1115698

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-597-60OSELTAMIVIR PHOSPHATE1 in 1 CARTONPOWDER, FOR SUSPENSION12
59651-597-60OSELTAMIVIR PHOSPHATE60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-597-60ML - Milliliter59651-59706ed65fb-9340-4f75-be04-b36e1bbbade012024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-597OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20240521_07958a9a-2360-4380-b7da-5371ed80a271.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN07958a9a-2360-4380-b7da-5371ed80a2712
1115698oseltamivir 6 MG/ML Oral SuspensionSCD07958a9a-2360-4380-b7da-5371ed80a2712
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY07958a9a-2360-4380-b7da-5371ed80a2712
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY07958a9a-2360-4380-b7da-5371ed80a2712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-597-60596510597601 BOTTLE, GLASS in 1 CARTON (59651-597-60) / 60 mL in 1 BOTTLE, GLASS2024-05-10NoNoCurrent