Home NDC 68071-2756-2 Ibuprofen
Product NDC 68071-2756
Requested package NDC 68071-2756-2
11-digit product format 680712756
Labeler code 68071
Product ID 68071-2756_e58375ab-7259-e5c2-e053-2a95a90ad4ae
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 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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 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.
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 68071-2756-2 Ibuprofen 20 in 1 BOTTLE TABLET, FILM COATED 20 2 68071-2756-5 Ibuprofen 50 in 1 BOTTLE TABLET, FILM COATED 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2756 IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 2 Legacy NDC, 2 package rows 20220808_e17f9b41-cac3-5613-e053-2a95a90ab909.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 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 RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68071-2756-2 68071275602 20 TABLET, FILM COATED in 1 BOTTLE (68071-2756-2) 2022-06-15 0000-00-00 No No Current