Home NDC 68196-980 Ibuprofen
Product NDC 68196-980
11-digit product format 681960980
Labeler code 68196
Product ID 68196-980_912e20c5-a582-4dc7-8145-add220729b11
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Sam's West, Inc.
Application ANDA206568
Marketing category ANDA
Marketing start 2017-11-13
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68196-980-38 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68196-980-41 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68196-980-38 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68196-980-41 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68196-980-38 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68196-980-41 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68196-980-38 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68196-980-41 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68196-980-38 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68196-980-41 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68196-980-38 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68196-980-41 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68196-980-38 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68196-980-41 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68196-980-38 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68196-980-41 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68196-980-38 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68196-980-41 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A206568-001 IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21
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 · 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 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 e64feba35796…
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 68196-980-38 Ibuprofen 200 in 1 BOTTLE CAPSULE, LIQUID FILLED 200 3 68196-980-41 Ibuprofen 200 in 1 BOTTLE CAPSULE, LIQUID FILLED 200 3 68196-980-41 Ibuprofen 2 in 1 PACKAGE CAPSULE, LIQUID FILLED 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68196-980 IBUPROFEN CAPSULE, LIQUID FILLED [SAM'S WEST, INC.] 3 Legacy NDC, 3 package rows 20191123_a5e618ba-a91f-49dc-bcc9-3b08c6daee07.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 3 · 46 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen minis IBUPROFEN Walgreens 6d1d131d-0741-4a75-8383-9322f4f3faab 2026-08-06 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Safeway, Inc. a530d43d-e9c4-4edb-af66-c92860e46f45 2026-07-23 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN P & L Development, LLC d0301d0d-fc65-420f-87fd-a08da1584d54 2026-06-08 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen Minis IBUPROFEN Vivunt Pharma LLC c46803db-feb7-435c-ac42-cffa99d35f46 2026-06-04 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN CVS Pharmacy 121b13c8-0b1a-4c48-9d57-3b53a9228d34 2026-05-22 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen minis IBUPROFEN CVS Pharmacy a6fc144a-6826-4bf7-8efb-8cdb896387f1 2026-05-12 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen minis IBUPROFEN Safeway, Inc. 22927a12-6837-4d57-8e60-043000f2f208 2026-01-05 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd 46a9424c-fd7d-f88b-e063-6294a90abceb 2025-12-24 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Family Dollar (FAMILY WELLNESS) 3a02af7e-7e69-45a6-97d7-ddc7d92b28b3 2025-10-22 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen Minis IBUPROFEN Family Dollar (FAMILY WELLNESS) 72f933d8-cf01-4bb6-a552-e3cdb297038b 2025-10-21 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN CVS Pharmacy e241ca5f-04bd-4bc9-bd0c-ca22841c4a3c 2025-07-01 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Chain Drug Consortium, LLC f0f01b97-e52c-4077-a4c6-c59736f4c171 2025-06-30 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen minis IBUPROFEN P & L Development, LLC 18b79fc5-57c8-46f1-81f3-2f9e189cdbcb 2025-05-16 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN AAFES/Your Military Exchanges 773b0230-a3a3-44e0-a22b-d143796ca365 2025-05-08 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen minis IBUPROFEN WR Group, Inc. e9dad35a-6789-42d6-97da-521db7b16496 2025-03-24 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Care One (Retail Business Services, LLC.) a6ce7484-7a32-4985-80bc-883c31be3525 2025-03-12 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Rugby Laboratories, Inc. 05c4e6c7-bf95-4e05-b7da-7a8778de342b 2024-10-28 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN P & L Development, LLC 1f9c94a6-938a-420f-b90c-36b3791e97ad 2024-10-07 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Sam's West, Inc 74ad11b9-8976-463d-89a3-2b9f5acd0c80 2024-04-01 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN The Kroger Co. a7789f7f-3356-463b-9fd7-2d7f7eba2799 2023-12-20 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568
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 68196-980-38 68196098038 200 CAPSULE, LIQUID FILLED in 1 BOTTLE (68196-980-38) 2017-11-13 0000-00-00 No No Current 68196-980-41 68196098041 2 BOTTLE in 1 PACKAGE (68196-980-41) > 200 CAPSULE, LIQUID FILLED in 1 BOTTLE 2 bottle 2017-11-13 0000-00-00 No No Current