Oseltamivir Phosphate

Product NDC
0527-5137
11-digit product format
005275137
Labeler code
0527
Product ID
0527-5137_187a99bd-1c9b-8eaf-e063-6394a90a2a74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA213594
Marketing category
ANDA
Marketing start
2023-07-13
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-5137-62Oseltamivir Phosphate60 mL in 1 BOTTLE, PLASTICSUSPENSION604
0527-5137-62Oseltamivir Phosphate1 in 1 CARTONSUSPENSION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-5137-62ML - Milliliter0527-5137f2916504-e44d-40c0-b7bf-f945a04d221612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-5137OSELTAMIVIR PHOSPHATE SUSPENSION [LANNETT COMPANY, INC.]4Current NDC, 2 package rows20240524_005b2784-e410-a50c-e063-6394a90a881c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN005b2784-e410-a50c-e063-6394a90a881c4
1115698oseltamivir 6 MG/ML Oral SuspensionSCD005b2784-e410-a50c-e063-6394a90a881c4
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY005b2784-e410-a50c-e063-6394a90a881c4
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY005b2784-e410-a50c-e063-6394a90a881c4
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN40390bf9-f2c4-4608-b5c4-315457b928211
1115698oseltamivir 6 MG/ML Oral SuspensionSCD40390bf9-f2c4-4608-b5c4-315457b928211
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY40390bf9-f2c4-4608-b5c4-315457b928211
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY40390bf9-f2c4-4608-b5c4-315457b928211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0527-5137-62005275137621 BOTTLE, PLASTIC in 1 CARTON (0527-5137-62) / 60 mL in 1 BOTTLE, PLASTIC2023-07-13NoNoCurrent