Home NDC 55154-4065-5 Ibuprofen
Product NDC 55154-4065
Requested package NDC 55154-4065-5
11-digit product format 551544065
Labeler code 55154
Product ID 55154-4065_e8950b71-4431-422e-b95d-f85570f2b6a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA074978
Marketing category ANDA
Marketing start 2019-02-01
Marketing end 2023-05-31
Substance IBUPROFEN
Active strength 100 mg/5mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074978-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074978-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074978-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB RS 1998-03-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55154-4065-5 55154406505 5 CUP, UNIT-DOSE in 1 BAG (55154-4065-5) > 5 mL in 1 CUP, UNIT-DOSE 2019-02-01 2023-05-31 No No Current