Home NDC 42677-320 Oseltamivir phosphate
Product NDC 42677-320
11-digit product format 426770320
Labeler code 42677
Product ID 42677-320_53b48bb4-e38e-bf3e-e063-6394a90a2cfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oseltamivir phosphate
Dosage form CAPSULE
Route ORAL
Labeler Shandong New Time Pharmaceutical Co., Ltd.
Application ANDA217274
Marketing category ANDA
Marketing start 2025-07-09
Substance OSELTAMIVIR PHOSPHATE
Active strength 30 mg/1
Pharmacologic classes Neuraminidase Inhibitor [EPC]; Neuraminidase Inhibitors [MoA]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217274-001 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2025-07-09 A217274-002 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2025-07-09 A217274-003 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2025-07-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217274-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2025-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217274-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2025-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217274-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2025-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217274-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2025-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217274-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2025-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217274-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2025-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217274-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2025-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217274-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2025-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217274-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2025-07-09 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217274-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2025-07-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217274-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2025-07-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217274-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2025-07-09 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Oseltamivir phosphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OSELTAMIVIR PHOSPHATE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4A3O49NGEZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312122 Internal RxNorm lookup 728109 Internal RxNorm lookup 728113 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 42677-320-01 42677032001 1 BLISTER PACK in 1 CARTON (42677-320-01) / 10 CAPSULE in 1 BLISTER PACK 1 blister pack 2025-07-09 0 Current