Home NDC 70518-2902 Ibuprofen
Product NDC 70518-2902
11-digit product format 705182902
Labeler code 70518
Product ID 70518-2902_59f4017c-2b3b-4974-e063-6294a90aa139
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA202413
Marketing category ANDA
Marketing start 2020-10-06
Substance IBUPROFEN
Active strength 600 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 2027-12-31
Current FDA listing Yes 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-2902-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-2902-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-2902-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-2902-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-2902-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-2902-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-2902-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-2902-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-2902-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-2902-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-2902-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-2902-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202413-001 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL AB 2016-11-23 A202413-002 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 2016-11-23 A202413-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL AB 2016-11-23 A202413-004 IBUPROFEN IBUPROFEN 300MG TABLET / ORAL 2024-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 143 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 A202413-001 IBUPROFEN 400MG TABLET / ORAL AB 2016-11-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202413-002 IBUPROFEN 600MG TABLET / ORAL AB 2016-11-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202413-003 IBUPROFEN 800MG TABLET / ORAL AB 2016-11-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202413-004 IBUPROFEN 300MG TABLET / ORAL 2024-07-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202413-001 IBUPROFEN 400MG TABLET / ORAL AB 2016-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202413-002 IBUPROFEN 600MG TABLET / ORAL AB 2016-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202413-003 IBUPROFEN 800MG TABLET / ORAL AB 2016-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202413-004 IBUPROFEN 300MG TABLET / ORAL 2024-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202413-001 IBUPROFEN 400MG TABLET / ORAL AB 2016-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202413-002 IBUPROFEN 600MG TABLET / ORAL AB 2016-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202413-003 IBUPROFEN 800MG TABLET / ORAL AB 2016-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202413-004 IBUPROFEN 300MG TABLET / ORAL 2024-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202413-001 IBUPROFEN 400MG TABLET / ORAL AB 2016-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202413-002 IBUPROFEN 600MG TABLET / ORAL AB 2016-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202413-003 IBUPROFEN 800MG TABLET / ORAL AB 2016-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202413-004 IBUPROFEN 300MG TABLET / ORAL 2024-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202413-001 IBUPROFEN 400MG TABLET / ORAL AB 2016-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202413-002 IBUPROFEN 600MG TABLET / ORAL AB 2016-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202413-003 IBUPROFEN 800MG TABLET / ORAL AB 2016-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202413-004 IBUPROFEN 300MG TABLET / ORAL 2024-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202413-001 IBUPROFEN 400MG TABLET / ORAL AB 2016-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202413-002 IBUPROFEN 600MG TABLET / ORAL AB 2016-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202413-003 IBUPROFEN 800MG TABLET / ORAL AB 2016-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202413-004 IBUPROFEN 300MG TABLET / ORAL 2024-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202413-001 IBUPROFEN 400MG TABLET / ORAL AB 2016-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202413-002 IBUPROFEN 600MG TABLET / ORAL AB 2016-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202413-003 IBUPROFEN 800MG TABLET / ORAL AB 2016-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202413-004 IBUPROFEN 300MG TABLET / ORAL 2024-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202413-001 IBUPROFEN 400MG TABLET / ORAL AB 2016-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202413-002 IBUPROFEN 600MG TABLET / ORAL AB 2016-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202413-003 IBUPROFEN 800MG TABLET / ORAL AB 2016-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202413-004 IBUPROFEN 300MG TABLET / ORAL 2024-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202413-001 IBUPROFEN 400MG TABLET / ORAL AB 2016-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202413-002 IBUPROFEN 600MG TABLET / ORAL AB 2016-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202413-003 IBUPROFEN 800MG TABLET / ORAL AB 2016-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202413-004 IBUPROFEN 300MG TABLET / ORAL 2024-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202413-001 IBUPROFEN 400MG TABLET / ORAL AB 2016-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202413-002 IBUPROFEN 600MG TABLET / ORAL AB 2016-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202413-003 IBUPROFEN 800MG TABLET / ORAL AB 2016-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202413-004 IBUPROFEN 300MG TABLET / ORAL 2024-07-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 600 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 197806 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2022-02-09 Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg 2022-02-09 Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg 2022-02-09 Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg 2022-01-28 Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg 2022-01-28 Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg 2022-01-28 Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-2902-0 Ibuprofen 30 in 1 BLISTER PACK TABLET, FILM COATED 30 5 70518-2902-1 Ibuprofen 50 in 1 BOX TABLET, FILM COATED 50 5 70518-2902-2 Ibuprofen 1 in 1 POUCH TABLET, FILM COATED 1 5
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 3 of 3 · 45 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN A-S Medication Solutions 0ce79e85-0b8b-436e-b895-ea5c02eaf4ba 2024-10-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202413 application number: ANDA202413 Ibuprofen IBUPROFEN A-S Medication Solutions 8d41cc03-dec6-4949-b7c1-7deb2897e2c4 2024-10-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202413 application number: ANDA202413 Ibuprofen IBUPROFEN Proficient Rx LP 43ac478c-43db-4136-8fee-4a43b09681e5 2024-10-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202413 application number: ANDA202413 Ibuprofen IBUPROFEN Asclemed USA, Inc. ca81671d-1ea8-4c67-802f-adb3a2f087cc 2024-09-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202413 application number: ANDA202413 Ibuprofen IBUPROFEN NuCare Pharmaceuticals, Inc. 214e3b3e-87b9-9ff5-e063-6394a90ae96a 2024-09-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202413 application number: ANDA202413
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 70518-2902-0 70518290200 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2902-0) 2020-10-06 0000-00-00 No No Current 70518-2902-1 70518290201 50 POUCH in 1 BOX (70518-2902-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-2902-2) 50 pouch 2026-04-23 No No Current 70518-2902-2 70518290202 1 in 1 POUCH Historical