FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
68180-678
11-digit product format
681800678
Labeler code
68180
Product ID
68180-678_7916db0e-271a-45a3-be4f-5ab7838a3127
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA208347
Marketing category
ANDA
Marketing start
2018-02-21
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-678-01Oseltamivir Phosphate60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION6011
68180-678-01Oseltamivir Phosphate1 in 1 CARTONPOWDER, FOR SUSPENSION111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-678OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 2 package rows20250206_b428e1f2-0082-4d9f-908e-e3633ea0457b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSNb428e1f2-0082-4d9f-908e-e3633ea0457b11
1115698oseltamivir 6 MG/ML Oral SuspensionSCDb428e1f2-0082-4d9f-908e-e3633ea0457b11
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSYb428e1f2-0082-4d9f-908e-e3633ea0457b11
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSYb428e1f2-0082-4d9f-908e-e3633ea0457b11
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN5194bb90-0876-48c4-a967-c862fbccd1105
1115698oseltamivir 6 MG/ML Oral SuspensionSCD5194bb90-0876-48c4-a967-c862fbccd1105
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY5194bb90-0876-48c4-a967-c862fbccd1105
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY5194bb90-0876-48c4-a967-c862fbccd1105
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSNc754c2f7-7109-4498-aeee-c8ee088dfa982
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN27894e4c-a7ec-48b6-83cc-048f244213a92
1115698oseltamivir 6 MG/ML Oral SuspensionSCD27894e4c-a7ec-48b6-83cc-048f244213a92
1115698oseltamivir 6 MG/ML Oral SuspensionSCDc754c2f7-7109-4498-aeee-c8ee088dfa982
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSYc754c2f7-7109-4498-aeee-c8ee088dfa982
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY27894e4c-a7ec-48b6-83cc-048f244213a92
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSYc754c2f7-7109-4498-aeee-c8ee088dfa982
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY27894e4c-a7ec-48b6-83cc-048f244213a92
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSNd9902b17-389b-45d4-b02f-67e35b0a5f3e1
1115698oseltamivir 6 MG/ML Oral SuspensionSCDd9902b17-389b-45d4-b02f-67e35b0a5f3e1
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSYd9902b17-389b-45d4-b02f-67e35b0a5f3e1
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSYd9902b17-389b-45d4-b02f-67e35b0a5f3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-678-01681800678011 BOTTLE, GLASS in 1 CARTON (68180-678-01) / 60 mL in 1 BOTTLE, GLASS2018-02-210000-00-00NoNoCurrent