FDA.reportPublic FDA data

Application 214781

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINTABLET, EXTENDED RELEASE;ORAL30MG;600MGNoNo
002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINTABLET, EXTENDED RELEASE;ORAL60MG;1.2GMNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-01
A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-01

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 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-01782e0a99824c…
2021-12-28 21:50 UTC2021-12A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-01782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214781-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2021-07-016a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214781-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2021-07-016a51e52b5d6a…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBROHM LABORATORIES INCf2eb5494-2672-444f-afa3-d1ef8ed1eaa12026-04-22WarningsExact identifier
application applno (ANDA): 214781
application number: ANDA214781
ndc (product): 51660-301
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INCdd00dfc0-e523-4dec-8fc0-50363eadec572026-04-20WarningsExact identifier
application applno (ANDA): 214781
application number: ANDA214781
ndc (product): 51316-600
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBROHM LABORATORIES INC07b9854d-1ec6-4c8a-983e-96ed1e2de1c22026-04-20WarningsExact identifier
application applno (ANDA): 214781
application number: ANDA214781
ndc (product): 51660-110
MUCUS RELIEF - DM MAXIMUM STRENGTHGUAIFENESIN, DEXTROMETHORPHAN HBRYYBA CORP325b5e55-ba58-312c-e063-6394a90aee552025-08-21WarningsExact identifier
application applno (ANDA): 214781
application number: ANDA214781
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRPUBLIX SUPER MARKETS, INC74fa022a-bad9-4d0f-8dda-5624fae3867b2025-02-10WarningsExact identifier
application applno (ANDA): 214781
application number: ANDA214781
ndc (product): 41415-998
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRPUBLIX SUPER MARKETS, INC9870b7ee-2bfb-42f5-9762-77d2dd13434a2022-12-06WarningsExact identifier
application applno (ANDA): 214781
application number: ANDA214781
ndc (product): 41415-999
Guaifenesin and Dextromethorphan Hydrobromide HBRGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDERITE-AID2343f031-d658-498a-b5d1-6dcdb26b3cf02022-12-06WarningsExact identifier
application applno (ANDA): 214781
application number: ANDA214781
ndc (product): 11822-9996
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRSUN PHARMACEUTICAL INDUSTRIES, INC.06328741-03e3-49cf-ae44-d4c2116e38a32022-12-06WarningsExact identifier
application applno (ANDA): 214781
application number: ANDA214781
ndc (product): 63304-106
ndc (product): 63304-110
GUAIFENESIN AND DEXTROMETHORPHAN HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRKroger Company11b3c01a-93c5-4cd1-8422-d3c3d19d8dff2022-05-24WarningsExact identifier
application applno (ANDA): 214781
application number: ANDA214781
ndc (product): 30142-948
GUAIFENESIN AND DEXTROMETHORPHAN HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRKroger Company8f7200ff-3e4d-414a-a1f9-fe8daac67cb12022-05-24WarningsExact identifier
application applno (ANDA): 214781
application number: ANDA214781
ndc (product): 30142-963

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11822-9996Guaifenesin and Dextromethorphan Hydrobromide HBRguaifenesin and dextromethorphan hydrobromideRITE-AIDANDACurrent
11822-9996Guaifenesin and Dextromethorphan Hydrobromide HBRguaifenesin and dextromethorphan hydrobromideRITE-AIDANDACurrent
30142-948GUAIFENESIN AND DEXTROMETHORPHAN HBRGuaifenesin and Dextromethorphan HBrKroger CompanyANDACurrent
30142-963GUAIFENESIN AND DEXTROMETHORPHAN HBRGuaifenesin and Dextromethorphan HBrKroger CompanyANDACurrent
41415-998Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HbrPUBLIX SUPER MARKETS, INCANDACurrent
41415-999Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrPUBLIX SUPER MARKETS, INCANDACurrent
41415-999Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrPUBLIX SUPER MARKETS, INCANDACurrent
51316-600Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan HydrobromideCVS PHARMACY, INCANDACurrent
51660-110Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrOHM LABORATORIES INCANDACurrent
51660-110Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrOHM LABORATORIES INCANDACurrent
51660-110Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrOHM LABORATORIES INCANDACurrent
51660-301Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrOHM LABORATORIES INCANDACurrent
51660-301Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrOHM LABORATORIES INCANDACurrent
63304-106Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUN PHARMACEUTICAL INDUSTRIES, INC.ANDACurrent
63304-106Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUN PHARMACEUTICAL INDUSTRIES, INC.ANDACurrent
63304-110Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUN PHARMACEUTICAL INDUSTRIES, INC.ANDACurrent
63304-110Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBrSUN PHARMACEUTICAL INDUSTRIES, INC.ANDACurrent
68196-997Guaifenesin and Dextromethorphan Hydrobromideguaifenesin and dextromethorphan hydrobromideSAM'S WEST INCANDACurrent