Home NDC 41520-495 CareOne Ibuprofen
Product NDC 41520-495
11-digit product format 415200495
Labeler code 41520
Product ID 41520-495_205f36be-471e-40e2-9377-84b1ed6962df
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Sales Company
Application ANDA077349
Marketing category ANDA
Marketing start 2016-07-20
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 2027-12-31
Current FDA listing Yes 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 A077349-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21
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 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base CareOne Ibuprofen
Listing expiration 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41520-495-71 CareOne Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 6 41520-495-71 CareOne Ibuprofen 50 in 1 BOTTLE TABLET, FILM COATED 50 6 41520-495-78 CareOne Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 6 41520-495-78 CareOne Ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-495 CAREONE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [AMERICAN SALES COMPANY] 5 Current NDC, Legacy NDC, 4 package rows 20231212_03cdff8a-8890-440d-82b5-54ce809f88cc.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 · 21 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 41520-495-71 41520049571 1 BOTTLE in 1 CARTON (41520-495-71) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2016-07-20 0000-00-00 No No Current 41520-495-78 41520049578 1 BOTTLE in 1 CARTON (41520-495-78) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2016-07-20 0000-00-00 No No Current