Home NDC 46708-415 OSELTAMIVIR
Product NDC 46708-415
11-digit product format 467080415
Labeler code 46708
Product ID 46708-415_d5e4bb9c-4af2-407a-8c7d-d4c9cb5117f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OSELTAMIVIR
Dosage form CAPSULE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA211823
Marketing category ANDA
Marketing start 2019-06-25
Substance OSELTAMIVIR PHOSPHATE
Active strength 75 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 A211823-001 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 A211823-002 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 A211823-003 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24
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 4 · 123 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 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211823-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2019-06-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211823-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2019-06-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211823-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2019-06-24 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base OSELTAMIVIR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OSELTAMIVIR PHOSPHATE 75 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-415-10 OSELTAMIVIR 10 in 1 CARTON CAPSULE 10 2 46708-415-10 OSELTAMIVIR 1 in 1 BLISTER PACK CAPSULE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-415 OSELTAMIVIR CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] 2 Current NDC, Legacy NDC, 2 package rows 20230202_0a7181a6-e9eb-4047-a26f-4268f174db16.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46708-415-10 46708041510 1 CARTON in 1 BLISTER PACK (46708-415-10) / 10 CAPSULE in 1 CARTON 1 carton 2019-06-25 0000-00-00 No No Current