Home NDC 45802-952 Ibuprofen
Product NDC 45802-952
11-digit product format 458020952
Labeler code 45802
Product ID 45802-952_155cb0b6-81cf-4187-a508-d22b47496707
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA076925
Marketing category ANDA
Marketing start 2004-12-08
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A076925-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076925-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45802-952-26 Ibuprofen 1 in 1 CARTON SUSPENSION 1 17 45802-952-26 Ibuprofen 120 mL in 1 BOTTLE SUSPENSION 120 17 45802-952-43 Ibuprofen 473 mL in 1 BOTTLE SUSPENSION 473 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 SORBITOL INACTIVE INGREDIENT 506T60A25R IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC] 5 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 CORN SYRUP INACTIVE INGREDIENT 9G5L16BK6N IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 3 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 CORN SYRUP INACTIVE INGREDIENT 9G5L16BK6N IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 Ibuprofen ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 Ibuprofen ACTIVE MOIETY WK2XYI10QM IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 butylparaben INACTIVE INGREDIENT 3QPI1U3FV8 IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 citric acid INACTIVE INGREDIENT 2968PHW8QP IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 CORN SYRUP INACTIVE INGREDIENT 9G5L16BK6N IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 sorbitol INACTIVE INGREDIENT 506T60A25R IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 water INACTIVE INGREDIENT 059QF0KO0R IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE IBUPROFEN SUSPENSION [STAT RX USA LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-952 IBUPROFEN SUSPENSION [PADAGIS ISRAEL PHARMACEUTICALS LTD] 15 Current NDC, Legacy NDC, 3 package rows 20240810_998f2fcf-0b40-4304-929f-7f2fa42f66d0.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 · 2 matching rows.
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 45802-952-26 45802095226 1 BOTTLE in 1 CARTON (45802-952-26) / 120 mL in 1 BOTTLE 1 bottle 2004-12-28 0000-00-00 No No Current 45802-952-43 45802095243 473 mL in 1 BOTTLE (45802-952-43) 473 ml 2004-12-08 0000-00-00 No No Current