Home NDC 68071-3778 Ibuprofen
Product NDC 68071-3778
11-digit product format 680713778
Labeler code 68071
Product ID 68071-3778_35acc4bb-0101-8c7c-e063-6394a90a4ac3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA202413
Marketing category ANDA
Marketing start 2024-05-23
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 2026-12-31
Current FDA listing Yes 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 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-3778-2 Ibuprofen 20 in 1 BOTTLE TABLET, FILM COATED 20 3 68071-3778-3 Ibuprofen 30 in 1 BOTTLE TABLET, FILM COATED 30 3 68071-3778-5 Ibuprofen 50 in 1 BOTTLE TABLET, FILM COATED 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3778 IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] 3 Current NDC, 3 package rows 20250523_2c3f8149-9b77-54cd-e063-6394a90a847e.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 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 Marketing start Sample Exclude flag Status 68071-3778-2 68071377802 20 TABLET, FILM COATED in 1 BOTTLE (68071-3778-2) 2025-01-29 No No Current 68071-3778-3 68071377803 30 TABLET, FILM COATED in 1 BOTTLE (68071-3778-3) 2025-01-21 No No Current 68071-3778-5 68071377805 50 TABLET, FILM COATED in 1 BOTTLE (68071-3778-5) 2025-05-21 No No Current