Home NDC 70000-0197 Ibuprofen
Product NDC 70000-0197
11-digit product format 700000197
Labeler code 70000
Product ID 70000-0197_d56fda29-9220-4ec8-862b-b716fbb88f9d
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Cardinal Health (Leader) 70000
Application ANDA078682
Marketing category ANDA
Marketing start 2016-11-30
Marketing end 2023-12-31
Substance IBUPROFEN
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A078682-001 IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24
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 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 e64feba35796…
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 · 60 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70000-0197-1 70000019701 1 BOTTLE, PLASTIC in 1 BOX (70000-0197-1) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2016-11-30 2022-12-31 No No Current 70000-0197-2 70000019702 1 BOTTLE, PLASTIC in 1 BOX (70000-0197-2) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2016-11-30 2022-12-31 No No Current