Home NDC 50804-199-40 Ibuprofen
Product NDC 50804-199
Requested package NDC 50804-199-40
11-digit product format 508040199
Labeler code 50804
Product ID 50804-199_2003f26d-7569-4b21-9f0b-a14c9e43aa16
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Good Sense (Geiss, Destin & Dunn, Inc.)
Application ANDA078682
Marketing category ANDA
Marketing start 2013-04-23
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD IBUPROFEN CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L IBUPROFEN CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T IBUPROFEN CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU IBUPROFEN CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R IBUPROFEN CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 WATER INACTIVE INGREDIENT 059QF0KO0R IBUPROFEN CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50804-199 IBUPROFEN CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 8 Legacy NDC 20230302_3c8d5ae9-6d18-4fc7-a13e-63a11f062fd0.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 · 60 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50804-199-40 50804019940 1 BOTTLE in 1 BOX (50804-199-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2013-04-23 0000-00-00 No No Current