Home NDC 49483-133 Ibuprofen
Product NDC 49483-133
11-digit product format 494830133
Labeler code 49483
Product ID 49483-133_059c51fc-6904-a427-e063-6294a90a7f69
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen Capsules 200 mg
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler TIME CAP LABORATORIES, INC.
Application ANDA079205
Marketing category ANDA
Marketing start 2021-07-27
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 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 A079205-001 IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26
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 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 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 310964 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 49483-133-12 Ibuprofen 120 in 1 BOTTLE CAPSULE, LIQUID FILLED 120 3 49483-133-20 Ibuprofen 200 in 1 BOTTLE CAPSULE, LIQUID FILLED 200 3 49483-133-23 Ibuprofen 20 in 1 BOTTLE CAPSULE, LIQUID FILLED 20 3 49483-133-23 Ibuprofen 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 3 49483-133-31 Ibuprofen 300 in 1 BOTTLE CAPSULE, LIQUID FILLED 300 3 49483-133-37 Ibuprofen 160 in 1 BOTTLE CAPSULE, LIQUID FILLED 160 3 49483-133-80 Ibuprofen 80 in 1 BOTTLE CAPSULE, LIQUID FILLED 80 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-133 IBUPROFEN (IBUPROFEN CAPSULES 200 MG) CAPSULE, LIQUID FILLED [TIME CAP LABORATORIES, INC.] 3 Current NDC, Legacy NDC, 7 package rows 20230918_c7c51cf3-9e95-f8d0-e053-2995a90a7371.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 · 25 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Harris Teeter 87ffbf01-54de-45a8-b2a3-367d21927882 2026-07-29 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen Minis IBUPROFEN Grocery Outlet, Inc. 44665e3d-37a7-a1a7-e063-6294a90ab376 2026-03-04 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN WALGREENS 40a1e525-fb1e-08f4-e063-6294a90adfa7 2026-01-14 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 IBUPROFEN IBUPROFEN TIME CAP LABORATORIES, INC e0a8315a-80a5-4be3-aad1-3d01f00df494 2025-12-29 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN AMERIFOODS TRADING COMPANY 3802ebc9-83ca-602a-e063-6294a90a11c8 2025-11-20 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN BJWC (Berkley & Jensen / BJ's) 2f322afb-bfc8-9dab-e063-6394a90a08b5 2025-08-19 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN FSA STORE INC. ec6b1b86-46fc-7e82-e053-2a95a90ac147 2025-08-12 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN MARC GLASSMAN, INC. 7f366669-9d31-46c7-932d-02fa64b11f30 2025-07-15 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI 37eaa3b1-98e9-4fcf-ae74-153bfc35551f 2025-07-01 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 IBUPROFEN IBUPROFEN SPIRIT PHARMACEUTICALS,LLC 2810122e-3c89-49a2-8dac-db3714cb7b45 2024-12-30 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN Winco Foods, LLC 61cd9140-eded-4bcf-894b-a163fa5f3e10 2024-12-06 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 PROPRINAL IBUPROFEN CAPSULES 200 MG HART Health ec27b625-a3fa-4c5f-8134-c9373c09b3e3 2024-12-04 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN BETTER LIVING BRANDS, LLC eb619068-be71-7569-e053-2a95a90a4a6e 2024-10-26 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 IBUPROFEN IBUPROFEN Kroger Company bc178013-ab2e-04f5-e053-2995a90a1ed4 2024-04-13 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN KROGER COMPANY 0fbe42d0-b5f0-0780-e063-6394a90a4ecb 2024-04-13 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 IBUPROFEN IBUPROFEN WALGREENS 3ce5b71b-f841-444f-bf66-023e4bd9aa16 2024-03-15 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 PROPRINAL IBUPROFEN CAPSULES 200 MG A-S Medication Solutions 4723dd14-5d20-4a9a-b127-4237d5db5956 2024-01-29 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 IBUPROFEN IBUPROFEN TARGET CORPORATION 8e8646fe-fd62-1662-e053-2a95a90a3008 2024-01-03 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen Mini IBUPROFEN MINI 200 MG TARGET CORPORATION c80426d9-e121-c24d-e053-2a95a90acf2f 2024-01-03 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN TIME CAP LABORATORIES, INC. 059cb22f-f6db-5d03-e063-6294a90a9ec1 2023-10-27 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205
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 49483-133-12 49483013312 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-12) 2022-06-16 0000-00-00 No No Current 49483-133-20 49483013320 200 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-20) 2022-06-16 0000-00-00 No No Current 49483-133-23 49483013323 1 BOTTLE in 1 CARTON (49483-133-23) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2022-06-16 0000-00-00 No No Current 49483-133-31 49483013331 300 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-31) 2021-07-27 0000-00-00 No No Current 49483-133-37 49483013337 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-37) 2023-09-16 No No Current 49483-133-80 49483013380 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-80) 2022-06-16 0000-00-00 No No Current