Home NDC 50844-291 Ibuprofen
Product NDC 50844-291
11-digit product format 508440291
Labeler code 50844
Product ID 50844-291_beb6ea94-7f3d-4d13-90a5-e717aa719050
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application ANDA075010
Marketing category ANDA
Marketing start 1988-05-24
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 2026-12-31
Current FDA listing Yes 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 A075010-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 1999-03-01
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 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310965 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50844-291-01 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 21 50844-291-01 Ibuprofen 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 21 50844-291-02 Ibuprofen 12 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 12 21 50844-291-02 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 21 50844-291-03 Ibuprofen 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 21 50844-291-08 Ibuprofen 24 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 24 21 50844-291-08 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 21 50844-291-10 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 21 50844-291-10 Ibuprofen 40 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 40 21 50844-291-11 Ibuprofen 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 21 50844-291-11 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 21 50844-291-12 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 21 50844-291-12 Ibuprofen 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 21 50844-291-13 Ibuprofen 250 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 250 21 50844-291-13 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 21 50844-291-14 Ibuprofen 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 21 50844-291-15 Ibuprofen 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 21 50844-291-15 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 21 50844-291-16 Ibuprofen 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 21 50844-291-17 Ibuprofen 300 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 300 21 50844-291-24 Ibuprofen 2 in 1 POUCH TABLET, FILM COATED 2 21 50844-291-29 Ibuprofen 150 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 150 21 50844-291-29 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 21 50844-291-50 Ibuprofen 50 in 1 CARTON TABLET, FILM COATED 50 21 50844-291-99 Ibuprofen 250 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 250 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 3 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-291 IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 20 Current NDC, Legacy NDC, 25 package rows 20240628_57b39311-bc20-ace6-75a9-a07a9311b373.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 · 53 matching rows.
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 50844-291-01 50844029101 1 BOTTLE, PLASTIC in 1 CARTON (50844-291-01) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 0000-00-00 No No Current 50844-291-02 50844029102 1 BOTTLE, PLASTIC in 1 CARTON (50844-291-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 0000-00-00 No No Current 50844-291-03 50844029103 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-03) 1988-05-24 0000-00-00 No No Current 50844-291-08 50844029108 1 BOTTLE, PLASTIC in 1 CARTON (50844-291-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 0000-00-00 No No Current 50844-291-10 50844029110 1 BOTTLE, PLASTIC in 1 CARTON (50844-291-10) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 0000-00-00 No No Current 50844-291-11 50844029111 1 BOTTLE, PLASTIC in 1 CARTON (50844-291-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 0000-00-00 No No Current 50844-291-12 50844029112 1 BOTTLE, PLASTIC in 1 CARTON (50844-291-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 0000-00-00 No No Current 50844-291-13 50844029113 1 BOTTLE, PLASTIC in 1 CARTON (50844-291-13) / 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 0000-00-00 No No Current 50844-291-14 50844029114 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-14) 1988-05-24 0000-00-00 No No Current 50844-291-15 50844029115 1 BOTTLE, PLASTIC in 1 CARTON (50844-291-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 0000-00-00 No No Current 50844-291-16 50844029116 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-16) 1988-05-24 0000-00-00 No No Current 50844-291-17 50844029117 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-17) 1988-05-24 No No Current 50844-291-24 50844029124 2 in 1 POUCH Historical 50844-291-29 50844029129 1 BOTTLE, PLASTIC in 1 CARTON (50844-291-29) / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1988-05-24 0000-00-00 No No Current 50844-291-50 50844029150 50 POUCH in 1 CARTON (50844-291-50) / 2 TABLET, FILM COATED in 1 POUCH (50844-291-24) 50 pouch 1988-05-24 No No Current 50844-291-99 50844029199 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-99) 1988-05-24 No No Current