Home NDC 57344-212-05 Ibuprofen
Product NDC 57344-212
Requested package NDC 57344-212-05
11-digit product format 573440212
Labeler code 57344
Product ID 57344-212_5e4baa16-d219-002c-e063-6394a90a290e
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, COATED
Route ORAL
Labeler AAA Pharmaceutical, Inc.
Application ANDA202312
Marketing category ANDA
Marketing start 2026-02-16
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 A202312-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2016-10-07
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 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 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
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 2 · 33 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 57344-212-05 57344021205 500 TABLET, COATED in 1 PACKAGE (57344-212-05) 2026-02-16 No No Current