Home NDC 67296-0913 IBU
Product NDC 67296-0913
11-digit product format 672960913
Labeler code 67296
Product ID 67296-0913_3251a7a8-7561-cf22-e063-6394a90adcb3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IBU
Dosage form TABLET
Route ORAL
Labeler RedPharm Drug, 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 2026-12-31
Current FDA listing Yes 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 67296-0913-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 67296-0913-3 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 67296-0913-1 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 67296-0913-3 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 67296-0913-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 67296-0913-3 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 67296-0913-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 67296-0913-3 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 67296-0913-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 67296-0913-3 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 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 · 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 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 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.
Additional Listing Data#
Finished product Yes
Brand name base IBU
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67296-0913-1 IBU 30 in 1 BOTTLE TABLET 30 6 67296-0913-3 IBU 10 in 1 BOTTLE TABLET 10 6 67296-0913-9 IBU 90 in 1 BOTTLE TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-0913 IBU TABLET [REDPHARM DRUG, INC.] 6 Current NDC, Legacy NDC, 3 package rows 20250410_4db219dc-ea48-490c-e054-00144ff88e88.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 67296-0913-1 67296091301 30 TABLET in 1 BOTTLE (67296-0913-1) 30 tablet 2008-11-20 0000-00-00 No No Current 67296-0913-3 67296091303 10 TABLET in 1 BOTTLE (67296-0913-3) 10 tablet 2008-11-20 0000-00-00 No No Current 67296-0913-9 67296091309 90 TABLET in 1 BOTTLE (67296-0913-9) 90 tablet 2008-11-20 No No Current