oseltamivir phosphate (69539-110)

Drug Facts

Product Profile

Brand Name oseltamivir phosphate

Generic Name oseltamivir phosphate

Labeler msn laboratories private limited

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

oseltamivir phosphate 45 mg/1

Manufacturer

MSN LABORATORIES PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 69539-110

Product ID 69539-110_1eceb65e-b7b6-42ff-9fb7-2d47a6e978c3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212544

Listing Expiration 2026-12-31

Marketing Start 2020-05-22

Pharmacologic Class

Classes

neuraminidase inhibitor [epc] neuraminidase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69539110

Hyphenated Format 69539-110

Supplemental Identifiers

RxCUI

312122 728109 728113

UNII

4A3O49NGEZ

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name oseltamivir phosphate (source: ndc)

Generic Name oseltamivir phosphate (source: ndc)

Application Number ANDA212544 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

45 mg/1

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING Oseltamivir Phosphate Capsules, USP 30-mg capsules (30 mg free base equivalent of the phosphate salt): Size "4" hard gelatin capsules with light yellow opaque colour body with black colour band, imprinted with "M" and light yellow opaque colour cap imprinted with "30 mg". Available in blister packages of 10 (NDC-69539-109-33). 45-mg capsules (45 mg free base equivalent of the phosphate salt): Size "4" hard gelatin capsules with grey opaque colour body with black colour band, imprinted with '' M " and grey opaque colour cap imprinted with "45mg". Available in blister packages of 10 (NDC 69539-110-33) 75-mg capsules (75 mg free base equivalent of the phosphate salt): Size "2" hard gelatin capsules with grey opaque colour body with black colour band, imprinted with "M" and light yellow opaque colour cap imprinted with "75 mg. Available in blister packages of 10 (NDC 69539-111-33). Storage Store the capsules at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Osletamivir-30mg-blister-carton-label Osletamivir-30mg-blister-foil-label Osletamivir-45mg-blister-carton-label Osletamivir-45mg-blister-foil-label Osletamivir-75mg-blister-carton-label Osletamivir-75mg-blister-foil-label 30-10s-blister 30mg-foil 45mg-10s-blister 45mg-foil 75mg-10s-blister 75mg-foil

source: label

Packages (0)

No package records.

Ingredients (1)

oseltamivir phosphate (45 mg/1)

Linked Drug Pages (1)

Oseltamivir phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "1eceb65e-b7b6-42ff-9fb7-2d47a6e978c3", "openfda": {"unii": ["4A3O49NGEZ"], "rxcui": ["312122", "728109", "728113"], "spl_set_id": ["1b7a02ca-ee0e-4853-91e6-71a79f2bc040"], "manufacturer_name": ["MSN LABORATORIES PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Oseltamivir phosphate", "product_id": "69539-110_1eceb65e-b7b6-42ff-9fb7-2d47a6e978c3", "dosage_form": "CAPSULE", "pharm_class": ["Neuraminidase Inhibitor [EPC]", "Neuraminidase Inhibitors [MoA]"], "product_ndc": "69539-110", "generic_name": "Oseltamivir phosphate", "labeler_name": "MSN LABORATORIES PRIVATE LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oseltamivir phosphate", "active_ingredients": [{"name": "OSELTAMIVIR PHOSPHATE", "strength": "45 mg/1"}], "application_number": "ANDA212544", "marketing_category": "ANDA", "marketing_start_date": "20200522", "listing_expiration_date": "20261231"}