Home NDC 59556-149 Ibuprofen
Product NDC 59556-149
11-digit product format 595560149
Labeler code 59556
Product ID 59556-149_ac8a65ce-e894-49ac-a9a0-9a1b7ce5bd04
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Strides Pharma Inc
Application ANDA214071
Marketing category ANDA
Marketing start 2022-08-09
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 50 mg/1.25mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A214071-001 IBUPROFEN IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09
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.
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 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 a50c72e98297…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59556-149-01 59556014901 1 BOTTLE, DROPPER in 1 CARTON (59556-149-01) > 15 mL in 1 BOTTLE, DROPPER 2022-08-09 0000-00-00 No No Current 59556-149-02 59556014902 1 BOTTLE, DROPPER in 1 CARTON (59556-149-02) > 30 mL in 1 BOTTLE, DROPPER 2022-08-09 0000-00-00 No No Current