Ibuprofen

Product NDC
0363-0197
11-digit product format
003630197
Labeler code
0363
Product ID
0363-0197_2794ba50-073e-4c9f-a466-31f69200cfec
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
ANDA078682
Marketing category
ANDA
Marketing start
2013-09-30
Marketing end
2021-12-30
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0363-0197DDiscontinued by firm2026-08-07
excluded packagepackage0363-01970363-0197-16DDiscontinued by firm2026-08-07
excluded packagepackage0363-01970363-0197-20DDiscontinued by firm2026-08-07
excluded packagepackage0363-01970363-0197-30DDiscontinued by firm2026-08-07
excluded packagepackage0363-01970363-0197-40DDiscontinued by firm2026-08-07
excluded packagepackage0363-01970363-0197-80DDiscontinued by firm2026-08-07

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 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-0197-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-0197-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-0197-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-0197-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-0197-80d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0197-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0197-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0197-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0197-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0197-80f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0197-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0197-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0197-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0197-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0197-802ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0197-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0197-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0197-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0197-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0197-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0197-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0197-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0197-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0197-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0197-80cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0197-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0197-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0197-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0197-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0197-80cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0197-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0197-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0197-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0197-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0197-80302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0197-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0197-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0197-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0197-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0197-80ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0197-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0197-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0197-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0197-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0197-800efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0197-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0197-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0197-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0197-16ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0197-80ad56d346431e…cc804d4bbf1e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078682-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243f01610625f2…
2019-09-15 20:21 UTC2019-09A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0197-80EA - Each0363-0197170accfb-6420-4a22-bb84-a81cbd36eba212017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDIBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]3
GELATININACTIVE INGREDIENT2G86QN327LIBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TIBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]3
SORBITANINACTIVE INGREDIENT6O92ICV9RUIBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]3
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]3
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]3

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 3 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen mini dye freeIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.552d9018-cc7e-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)fb842f4d-1228-9a52-e053-6294a90adb412026-06-26WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Ibuprofen Mini Dye FreeIBUPROFENCVS Pharmacy42c7dbec-2e53-70ae-e063-6294a90a16e62026-06-25WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)c62cc12f-5a0e-389a-e053-2995a90a208c2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)c6297c23-3b27-c0c6-e053-2995a90a3e762026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.a139e495-3dbf-4998-e053-2a95a90ac1362026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
pain reliefIBUPROFENBionpharma Inc.a14ca126-fada-c903-e053-2995a90ae72d2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENHEBca4be24c-5d92-ddc9-e053-2a95a90aa5a72026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENDOLGENCORP INC03138a6f-653a-f359-e063-6394a90ac5d62026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFEN CAPSULEPUBLIX SUPER MARKETS INC10a6eba7-e400-ce97-e063-6294a90af3bd2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IBUPROFENIBUPROFENDISCOUNT DRUG MART, INC.d07ea9e3-88b0-4aa0-903a-10555dcca37d2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENDISCOUNT DRUG MART, INC.aae40114-343e-12da-e053-2a95a90a92132026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENBJWC0ca0b6cf-7d1f-4673-b9b9-48f78d80c00a2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
pain reliefIBUPROFENBionpharma Inc.2b4ecdd8-627a-445f-8ddc-f2b6c832c1e82026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
dye-free pain reliefIBUPROFENBionpharma Inc.c46c9c36-8844-7b50-e053-2a95a90aa0e92026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
dye-free pain reliefIBUPROFENBionpharma Inc.4227d0b7-846a-dcb0-e063-6294a90af7d72026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.3c1c1b65-f57f-62b0-e063-6294a90a10212026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3802982a-2373-9ca3-e063-6394a90a0ab72026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.4573753d-117b-a6f2-e063-6394a90ae2f92026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3ed7faff-fd48-0a83-e063-6394a90aab142026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0197-16003630197161 BOTTLE, PLASTIC in 1 BOX (0363-0197-16) > 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2013-09-302021-12-30NoNoCurrent
0363-0197-20003630197201 BOTTLE, PLASTIC in 1 BOX (0363-0197-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2013-09-302021-12-30NoNoCurrent
0363-0197-3000363019730300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0197-30) 2013-09-302021-12-30NoNoCurrent
0363-0197-40003630197401 BOTTLE, PLASTIC in 1 BOX (0363-0197-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2013-09-302021-12-30NoNoCurrent
0363-0197-80003630197801 BOTTLE, PLASTIC in 1 BOX (0363-0197-80) > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2013-09-302021-12-30NoNoCurrent