Home NDC 0527-4592 Oseltamivir Phosphate
Product NDC 0527-4592
11-digit product format 005274592
Labeler code 0527
Product ID 0527-4592_00e310fb-2460-a1bf-e063-6394a90a2457
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oseltamivir phosphate
Dosage form CAPSULE
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA212739
Marketing category ANDA
Marketing start 2023-05-15
Substance OSELTAMIVIR PHOSPHATE
Active strength 45 mg/1
Pharmacologic classes Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 A212739-001 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 A212739-002 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 A212739-003 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04
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.
Product history page 1 of 3 · 111 observed 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 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212739-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2020-03-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212739-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212739-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2020-03-04 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oseltamivir Phosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OSELTAMIVIR PHOSPHATE 45 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-4592-13 Oseltamivir Phosphate 10 in 1 BLISTER PACK CAPSULE 10 1 0527-4592-13 Oseltamivir Phosphate 1 in 1 CARTON CAPSULE 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-4592 OSELTAMIVIR PHOSPHATE CAPSULE [LANNETT COMPANY, INC.] 1 Current NDC, 2 package rows 20230720_00e2e995-6296-b544-e063-6294a90a8345.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0527-4592-13 00527459213 1 BLISTER PACK in 1 CARTON (0527-4592-13) / 10 CAPSULE in 1 BLISTER PACK 1 blister pack 2023-05-15 No No Current