Home NDC 68788-9111 Ibuprofen
Product NDC 68788-9111
11-digit product format 687889111
Labeler code 68788
Product ID 68788-9111_421ee301-7aef-4484-9572-3eb0c463ef8b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA075682
Marketing category ANDA
Marketing start 2008-11-20
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A075682-001 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 A075682-002 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 A075682-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14
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 · 132 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 2026-10-15 13:18:30 2026-09 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197805 Internal RxNorm lookup 197806 Internal RxNorm lookup 197807 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ibuprofen ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 Ibuprofen ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 polydextrose INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-9111 IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 15 Current NDC, Legacy NDC, 8 package rows 20240526_72ec2491-924d-460f-9510-62d624d54b59.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 2 of 2 · 21 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join IBU IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC ffec2f44-1144-4729-b43a-1db40ea6a8d3 2019-05-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075682 application number: ANDA075682
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 68788-9111-1 68788911101 100 TABLET in 1 BOTTLE (68788-9111-1) 100 tablet 2008-11-20 0000-00-00 No No Current 68788-9111-2 68788911102 20 TABLET in 1 BOTTLE (68788-9111-2) 20 tablet 2008-11-20 0000-00-00 No No Current 68788-9111-3 68788911103 30 TABLET in 1 BOTTLE (68788-9111-3) 30 tablet 2008-11-20 0000-00-00 No No Current 68788-9111-5 68788911105 50 TABLET in 1 BOTTLE (68788-9111-5) 50 tablet 2008-11-20 0000-00-00 No No Current 68788-9111-6 68788911106 60 TABLET in 1 BOTTLE (68788-9111-6) 60 tablet 2008-11-20 0000-00-00 No No Current 68788-9111-7 68788911107 21 TABLET in 1 BOTTLE (68788-9111-7) 21 tablet 2008-11-20 0000-00-00 No No Current 68788-9111-8 68788911108 120 TABLET in 1 BOTTLE (68788-9111-8) 120 tablet 2008-11-20 0000-00-00 No No Current 68788-9111-9 68788911109 90 TABLET in 1 BOTTLE (68788-9111-9) 90 tablet 2008-11-20 0000-00-00 No No Current