Home NDC 55700-445 Ibuprofen
Product NDC 55700-445
11-digit product format 557000445
Labeler code 55700
Product ID 55700-445_c1af9352-c277-499c-9e24-ef955e0ac013
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA091625
Marketing category ANDA
Marketing start 2015-12-21
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 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A091625-001 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 A091625-002 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 A091625-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15
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 · 129 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 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 301d65b070ca…
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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55700-445 IBUPROFEN TABLET, FILM COATED [QUALITY CARE PRODUCTS LLC] 10 Legacy NDC 20241219_e9a5f214-a387-4429-a875-eb1e9aa714c1.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 · 41 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 4a86a190-da5d-4b7a-a05f-e3e7ccbfa603 2019-01-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55700-445-00 55700044500 100 TABLET, FILM COATED in 1 BOTTLE (55700-445-00) 2016-10-17 0000-00-00 No No Current 55700-445-20 55700044520 20 TABLET, FILM COATED in 1 BOTTLE (55700-445-20) 2016-10-17 0000-00-00 No No Current 55700-445-30 55700044530 30 TABLET, FILM COATED in 1 BOTTLE (55700-445-30) 2016-10-17 0000-00-00 No No Current 55700-445-40 55700044540 40 TABLET, FILM COATED in 1 BOTTLE (55700-445-40) 2016-10-17 0000-00-00 No No Current 55700-445-60 55700044560 60 TABLET, FILM COATED in 1 BOTTLE (55700-445-60) 2016-10-17 0000-00-00 No No Current 55700-445-90 55700044590 90 TABLET, FILM COATED in 1 BOTTLE (55700-445-90) 2016-10-17 0000-00-00 No No Current