Home NDC 59556-876 Ibuprofen
Product NDC 59556-876
11-digit product format 595560876
Labeler code 59556
Product ID 59556-876_4cd77671-6091-4bd0-9a34-8650001b9fdd
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Strides Pharma Inc
Application ANDA211666
Marketing category ANDA
Marketing start 2022-02-21
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record 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 A211666-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22
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 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211666-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2021-02-22 a50c72e98297…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59556-876-01 Ibuprofen 1 in 1 CARTON SUSPENSION 1 4 59556-876-01 Ibuprofen 240 mL in 1 BOTTLE, PLASTIC SUSPENSION 240 4 59556-876-72 Ibuprofen 1 in 1 CARTON SUSPENSION 1 4 59556-876-72 Ibuprofen 120 mL in 1 BOTTLE, PLASTIC SUSPENSION 120 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59556-876 IBUPROFEN SUSPENSION [STRIDES PHARMA INC] 4 Legacy NDC, 4 package rows 20250325_c3c600dd-6eec-4304-868e-9642de5e1dac.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 Marketing start Marketing end Sample Exclude flag Status 59556-876-01 59556087601 1 in 1 CARTON Historical 59556-876-72 59556087672 1 BOTTLE, PLASTIC in 1 CARTON (59556-876-72) > 120 mL in 1 BOTTLE, PLASTIC 2022-02-21 0000-00-00 No No Current