Home NDC 63548-0234-2 Ibuprofen
Product NDC 63548-0234
Requested package NDC 63548-0234-2
11-digit product format 635480234
Labeler code 63548
Product ID 63548-0234_60c49378-684f-4a8d-b51d-e58014a7ecf9
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076460-001 IBUPROFEN 200MG TABLET / ORAL 2003-11-26 caaa826d4ba7…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…
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 200 mg/1
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
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 63548-0234-2 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