Home NDC 0363-0057 Ibuprofen
Product NDC 0363-0057
11-digit product format 003630057
Labeler code 0363
Product ID 0363-0057_ce3ff7d9-e0bb-49cd-b576-4d48e00a4dd6
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Walgreen Company
Application ANDA075217
Marketing category ANDA
Marketing start 2001-04-13
Marketing end 2021-01-31
Substance IBUPROFEN
Active strength 50 mg/1.25mL
NDC exclude flag No
Listing certified through 0000-00-00
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075217-001 IBUPROFEN IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16
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 2 · 41 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 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 cb3db0bc1861…
DailyMed Socrata Ingredients# 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 2 · 30 matching rows.