Home NDC 49483-601-50 IBUPROFEN
Product NDC 49483-601
Requested package NDC 49483-601-50
11-digit product format 494830601
Labeler code 49483
Product ID 49483-601_375d8923-4e92-d631-e063-6294a90a20eb
Type HUMAN OTC DRUG
Nonproprietary name IBUPROFEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler TIME CAP LABORATORIES,INC
Application ANDA091239
Marketing category ANDA
Marketing start 2016-03-22
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, 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 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 A091239-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2011-02-01
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 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 cb3db0bc1861…
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49483-601-00 IBUPROFEN 6500 in 1 BAG TABLET, FILM COATED 6500 12 49483-601-01 IBUPROFEN 100 in 1 BOTTLE TABLET, FILM COATED 100 12 49483-601-05 IBUPROFEN 50 in 1 BOTTLE TABLET, FILM COATED 50 12 49483-601-10 IBUPROFEN 1000 in 1 BOTTLE TABLET, FILM COATED 1000 12 49483-601-50 IBUPROFEN 500 in 1 BOTTLE TABLET, FILM COATED 500 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-601 IBUPROFEN TABLET, FILM COATED IBUPROFEN TABLET, FILM COATED IBUPROFEN (IBUPFROFEN) TABLET, FILM COATED [TIME CAP LABORATORIES,INC] 11 Current NDC, Legacy NDC, 5 package rows 20231123_f58d35f9-e44b-417b-98ce-0766b537cd2f.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 · 16 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 49483-601-50 49483060150 500 TABLET, FILM COATED in 1 BOTTLE (49483-601-50) 2016-03-22 0000-00-00 No No Current