Home NDC 68071-2798 Ibuprofen
Product NDC 68071-2798
11-digit product format 680712798
Labeler code 68071
Product ID 68071-2798_e42c47b1-e6d0-3100-e053-2995a90ae8be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA071268
Marketing category ANDA
Marketing start 2021-10-21
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 400 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 68071-2798 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68071-2798 68071-2798-9 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product 68071-2798 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68071-2798 68071-2798-9 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 68071-2798 I Inactivated by FDA excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68071-2798 68071-2798-9 I Inactivated by FDA excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product 68071-2798 I Inactivated by FDA excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68071-2798 68071-2798-9 I Inactivated by FDA excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product 68071-2798 I Inactivated by FDA excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68071-2798 68071-2798-9 I Inactivated by FDA excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product 68071-2798 I Inactivated by FDA excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68071-2798 68071-2798-9 I Inactivated by FDA excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 68071-2798 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-2798 68071-2798-9 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 68071-2798 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-2798 68071-2798-9 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 68071-2798 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-2798 68071-2798-9 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071268-001 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 A071268-002 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 A071268-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01
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 · 123 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 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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 1 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Major Pharmaceuticals 42b6faf5-ef47-6a7a-e063-6394a90ac409 2026-02-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071268 application number: ANDA071268 Ibuprofen IBUPROFEN NuCare Pharmaceuticals,Inc. f4d6372a-d560-0e14-e053-2a95a90a435a 2024-12-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071268 application number: ANDA071268 Ibuprofen IBUPROFEN Florida Pharmaceutical Products, LLC c1733fdb-5eed-2094-e053-2995a90a6c8e 2024-08-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071268 application number: ANDA071268
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-2798-9 Ibuprofen 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2798 IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 1 Legacy NDC, 1 package rows 20220721_e42c49db-7e6e-5fac-e053-2995a90a7c8a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68071-2798-9 68071279809 90 TABLET, FILM COATED in 1 BOTTLE (68071-2798-9) 2022-07-19 0000-00-00 No No Current