Home NDC 68788-8148 ibuprofen
Product NDC 68788-8148
11-digit product format 687888148
Labeler code 68788
Product ID 68788-8148_372072a6-a00b-4642-b6fa-3f3f41769d2d
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA072096
Marketing category ANDA
Marketing start 2022-03-03
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A072096-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 1987-12-08
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 · 44 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 2026-10-15 13:18:30 2026-09 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072096-001 IBUPROFEN 200MG TABLET / ORAL 1987-12-08 3a93d1ddd44b…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8148 IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] 3 Legacy NDC 20240524_372072a6-a00b-4642-b6fa-3f3f41769d2d.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 2 of 4 · 62 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68788-8148-1 68788814801 100 TABLET, FILM COATED in 1 BOTTLE (68788-8148-1) 2022-03-03 0000-00-00 No No Current 68788-8148-2 68788814802 20 TABLET, FILM COATED in 1 BOTTLE (68788-8148-2) 2022-03-03 0000-00-00 No No Current 68788-8148-3 68788814803 30 TABLET, FILM COATED in 1 BOTTLE (68788-8148-3) 2022-03-03 0000-00-00 No No Current 68788-8148-4 68788814804 40 TABLET, FILM COATED in 1 BOTTLE (68788-8148-4) 2022-03-03 0000-00-00 No No Current 68788-8148-5 68788814805 50 TABLET, FILM COATED in 1 BOTTLE (68788-8148-5) 2022-03-03 0000-00-00 No No Current 68788-8148-6 68788814806 60 TABLET, FILM COATED in 1 BOTTLE (68788-8148-6) 2022-03-03 0000-00-00 No No Current 68788-8148-9 68788814809 90 TABLET, FILM COATED in 1 BOTTLE (68788-8148-9) 2022-03-03 0000-00-00 No No Current