Home NDC 63548-0234 Ibuprofen
Product NDC 63548-0234
11-digit product format 635480234
Labeler code 63548
Product ID 63548-0234_616902bc-ffd6-41d3-ae4d-6e30519147c0
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, COATED
Route ORAL
Labeler PLD Acquisitions LLC DBA Av�ma Pharma Solutions
Application ANDA076460
Marketing category ANDA
Marketing start 2013-08-01
Substance IBUPROFEN
Active strength 200 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 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 A076460-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2003-11-26
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 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 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 310965 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 63548-0234-1 Ibuprofen 10 in 1 VIAL TABLET, COATED 10 4 63548-0234-2 Ibuprofen 1 in 1 BOX TABLET, COATED 1 4 63548-0234-2 Ibuprofen 100 in 1 BOTTLE TABLET, COATED 100 4 63548-0234-3 Ibuprofen 1000 in 1 BOTTLE TABLET, COATED 1000 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63548-0234 IBUPROFEN TABLET, COATED [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS] 4 Current NDC, Legacy NDC, 4 package rows 20230210_1662a495-4f6a-4515-a405-557681e1a496.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 63548-0234-1 63548023401 10 TABLET, COATED in 1 VIAL (63548-0234-1) 2013-08-01 0000-00-00 No No Current 63548-0234-2 63548023402 1 BOTTLE in 1 BOX (63548-0234-2) / 100 TABLET, COATED in 1 BOTTLE 1 bottle 2013-08-01 0000-00-00 No No Current 63548-0234-3 63548023403 1000 TABLET, COATED in 1 BOTTLE (63548-0234-3) 2013-08-01 0000-00-00 No No Current