Home NDC 70518-4595-0 Ibuprofen
Product NDC 70518-4595
Requested package NDC 70518-4595-0
11-digit product format 705184595
Labeler code 70518
Product ID 70518-4595_4dc63099-bda6-c9ae-e063-6394a90af398
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA209204
Marketing category ANDA
Marketing start 2026-03-24
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 A209204-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2017-06-23 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4595-0 Ibuprofen 118 mL in 1 BOTTLE SUSPENSION 118 1 70518-4595-0 Ibuprofen 1 in 1 CARTON SUSPENSION 1 1
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 ndc (package): 70518-4595-0 ndc (product): 70518-4595 ndc11 (package): 70518459500 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4595-0 70518459500 1 BOTTLE in 1 CARTON (70518-4595-0) / 118 mL in 1 BOTTLE 1 bottle 2026-03-24 No No Current