Home NDC 72476-358 Ibuprofen
Product NDC 72476-358
11-digit product format 724760358
Labeler code 72476
Product ID 72476-358_465173ac-4bc9-6b69-e063-6394a90ab6d2
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler RETAIL BUSINESS SERVICES,LLC.
Application ANDA202312
Marketing category ANDA
Marketing start 2020-07-26
Substance IBUPROFEN
Active strength 200 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 72476-358-10 fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 72476-358-05 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 72476-358-10 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 72476-358-05 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 72476-358-10 bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 72476-358-05 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 72476-358-10 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 72476-358-05 8dfbde2a14a4…c9ff85d89658…
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 A202312-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2016-10-07
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 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310965 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72476-358-05 Ibuprofen 50 in 1 BOTTLE TABLET 50 5 72476-358-10 Ibuprofen 100 in 1 BOTTLE TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72476-358 IBUPROFEN TABLET [RETAIL BUSINESS SERVICES,LLC.] 4 Current NDC, Legacy NDC, 2 package rows 20241212_a568fd1e-9bf0-3c03-e053-2a95a90a45b7.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 2 · 32 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72476-358-05 72476035805 50 TABLET in 1 BOTTLE (72476-358-05) 50 tablet 2020-07-26 0000-00-00 No No Current 72476-358-10 72476035810 100 TABLET in 1 BOTTLE (72476-358-10) 100 tablet 2020-07-26 0000-00-00 No No Current