Home NDC 53002-3370 IBU
Product NDC 53002-3370
11-digit product format 530023370
Labeler code 53002
Product ID 53002-3370_6c48a385-0433-4060-bc76-01b454e81a7c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA075682
Marketing category ANDA
Marketing start 2008-11-20
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 400 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 40 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-3370-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-3370-5 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-3370-3 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-3370-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-3370-5 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-3370-3 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-3370-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-3370-5 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-3370-3 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-3370-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-3370-5 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-3370-3 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-3370-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-3370-5 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-3370-3 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-3370-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-3370-5 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-3370-3 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-3370-3 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-3370-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-3370-5 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-3370-3 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-3370-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-3370-5 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-3370-3 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-3370-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-3370-5 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53002-3370-1 E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53002-3370-5 E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53002-3370-3 E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…
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.
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 53002-3370-1 IBU 15 in 1 BOTTLE TABLET 15 7 53002-3370-3 IBU 30 in 1 BOTTLE TABLET 30 7 53002-3370-5 IBU 50 in 1 BOTTLE TABLET 50 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-3370 IBU (IBUPROFEN) TABLET [RPK PHARMACEUTICALS, INC.] 7 Legacy NDC, 3 package rows 20230609_e25dd2e8-a1d4-4098-9b8a-c20a635969d4.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 53002-3370-1 53002337001 15 TABLET in 1 BOTTLE (53002-3370-1) 15 tablet 2017-10-01 0000-00-00 No No Current 53002-3370-3 53002337003 30 TABLET in 1 BOTTLE (53002-3370-3) 30 tablet 2017-10-01 0000-00-00 No No Current 53002-3370-5 53002337005 50 TABLET in 1 BOTTLE (53002-3370-5) 50 tablet 2017-10-01 0000-00-00 No No Current