Ibuprofen and Pseudoephedrine hydrochloride

Product NDC
63629-5284
11-digit product format
636295284
Labeler code
63629
Product ID
63629-5284_7249b0f9-b24c-4f7f-81f2-22473a4d5b0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen and pseudoephedrine hydrochloride
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074567
Marketing category
ANDA
Marketing start
2001-10-13
Marketing end
0000-00-00
Substance
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
200 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-5284DDiscontinued by firm2026-08-03
excluded packagepackage63629-528463629-5284-1DDiscontinued by firm2026-08-03
excluded packagepackage63629-528463629-5284-2DDiscontinued by firm2026-08-03

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 1 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-5284-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-5284-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5284-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5284-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5284-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5284-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5284-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5284-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5284-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5284-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5284-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5284-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-5284-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-5284-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-5284-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-5284-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-5284-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-5284-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-5284-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-5284-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-5284-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-5284-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-5284-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-5284-2DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-5284-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-5284-2IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-5284-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-5284-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-5284-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-5284-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-5284-1IInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-5284-2IInactivated by FDA110d247fa046…a55b01930146…

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
A074567-001IBUPROHM COLD AND SINUSIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2001-04-17

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 UTC2026-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
ACACIAINACTIVE INGREDIENT5C5403N26OIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
CROSPOVIDONEINACTIVE INGREDIENT68401960MKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
GUAR GUMINACTIVE INGREDIENTE89I1637KEIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
KAOLININACTIVE INGREDIENT24H4NWX5COIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94EIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
SHELLACINACTIVE INGREDIENT46N107B71OIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
SUCROSEINACTIVE INGREDIENTC151H8M554IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen and Pseudoephedrine hydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.65ec0f85-7ca3-4adc-b152-a0ae2fd0692f2025-02-27WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEThe Kroger Company2c15339d-a33b-4884-87d8-a3b50903a2c82024-12-27WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLCd93ae778-e6e9-4d1d-8f46-c04d962a93932024-11-22WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN COMPANYc3b302c6-a2d2-491c-8f56-ecc25dd1f6c02022-10-07WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDERite-Aid483c3bb7-529e-4684-80e1-6646b050988e2022-01-26WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy627ea7db-47f1-40c2-b1ca-72dc66542e4a2021-12-21WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.c0692a21-358d-47b9-bbff-cc8f4f3bdb562020-09-09WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine hydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.cb7fb0d3-adf6-4c14-ac61-103dc869ebf22020-09-09WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc2b98a62b-bd92-4fb8-ad0f-521cb477b6122018-10-23WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-5284-16362952840130 TABLET, SUGAR COATED in 1 BOTTLE (63629-5284-1) 2022-02-080000-00-00NoNoCurrent
63629-5284-26362952840220 TABLET, SUGAR COATED in 1 BOTTLE (63629-5284-2) 2014-03-310000-00-00NoNoCurrent