Home NDC 48792-7813 Ibuprofen
Product NDC 48792-7813
11-digit product format 487927813
Labeler code 48792
Product ID 48792-7813_84f5a057-bb87-2c2b-e053-2991aa0ad665
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sunshine Lake Pharma Co., Ltd.
Application ANDA204062
Marketing category ANDA
Marketing start 2018-09-24
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 400 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 48792-7813-1 d630ba8d3edf…732f749b63fb…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 48792-7813-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 48792-7813-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 48792-7813-1 557ba5c1ecfa…9c80585c8c6e…
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 A204062-001 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL 2018-09-10 A204062-002 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL 2018-09-10 A204062-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL 2018-09-10
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 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 8072bd15b7f6…
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 48792-7813 IBUPROFEN TABLET, FILM COATED [SUNSHINE LAKE PHARMA CO., LTD.] 6 Legacy NDC 20241210_76ad62e9-4784-fe61-e053-2a91aa0aee8b.zip