Home NDC 51672-1409 Ibuprofen
Product NDC 51672-1409
11-digit product format 516721409
Labeler code 51672
Product ID 51672-1409_39624591-4c56-0f24-e063-6394a90ae7f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA209204
Marketing category ANDA
Marketing start 2017-06-23
Substance IBUPROFEN
Active strength 100 mg/5mL
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 51672-1409-9 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 51672-1409-8 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 51672-1409-9 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 51672-1409-8 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 51672-1409-9 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 51672-1409-8 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 51672-1409-9 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 51672-1409-8 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209204-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209204-001 AB
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 100 mg/5mL
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 197803 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 51672-1409-8 Ibuprofen 118 mL in 1 BOTTLE SUSPENSION 118 7 51672-1409-8 Ibuprofen 1 in 1 CARTON SUSPENSION 1 7 51672-1409-9 Ibuprofen 473 mL in 1 BOTTLE SUSPENSION 473 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1409 IBUPROFEN SUSPENSION [-SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 Current NDC, Legacy NDC, 3 package rows 20250406_398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e.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 1 of 1 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN REMEDYREPACK INC. dda7645f-1666-4c1f-b974-01add2ea79ac 2026-03-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209204 application number: ANDA209204 Ibuprofen IBUPROFEN Sun Pharmaceutical Industries, Inc. a8b46ae5-67bc-494d-850e-b4e4ed5a33b3 2025-12-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209204 application number: ANDA209204 Ibuprofen IBUPROFEN Sun Pharmaceutical Industries, Inc. 398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e 2025-07-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209204 application number: ANDA209204 ndc (product): 51672-1409
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 51672-1409-8 51672140908 1 BOTTLE in 1 CARTON (51672-1409-8) / 118 mL in 1 BOTTLE 1 bottle 2022-07-06 0000-00-00 No No Current 51672-1409-9 51672140909 473 mL in 1 BOTTLE (51672-1409-9) 473 ml 2022-07-06 0000-00-00 No No Current