Home NDC 68210-0009-1 IBUPROFEN
Product NDC 68210-0009
Requested package NDC 68210-0009-1
11-digit product format 682100009
Labeler code 68210
Product ID 68210-0009_ee03445d-01db-a710-e053-2995a90a57a2
Type HUMAN OTC DRUG
Nonproprietary name IBUPROFEN
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler SPIRIT PHARMACEUTICALS,LLC
Application ANDA079205
Marketing category ANDA
Marketing start 2017-11-22
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 AMMONIA INACTIVE INGREDIENT 5138Q19F1X IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 SORBITAN MONOOLEATE INACTIVE INGREDIENT 06XEA2VD56 IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC] 2
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68210-0009-1 68210000901 1 BOTTLE in 1 CARTON (68210-0009-1) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2017-11-22 0000-00-00 No No Current