Home NDC 68016-295 Ibuprofen
Product NDC 68016-295
11-digit product format 680160295
Labeler code 68016
Product ID 68016-295_733d3671-2924-49d3-ad1d-c577a441ace8
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chain Drug Consortium LLC
Application ANDA091237
Marketing category ANDA
Marketing start 2013-05-07
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 63 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A091237-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2011-02-08
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 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091237-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-08 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 68016-295-01 Ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 1 68016-295-01 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 1 68016-295-50 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 1 68016-295-50 Ibuprofen 50 in 1 BOTTLE TABLET, FILM COATED 50 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM LLC] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM LLC] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-295 IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM LLC] 1 Legacy NDC, 4 package rows 20130507_733d3671-2924-49d3-ad1d-c577a441ace8.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 · 12 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68016-295-01 68016029501 100 in 1 BOTTLE Historical 68016-295-50 68016029550 1 in 1 CARTON Historical