Application 040245

Type
ANDA
Sponsor
ALLIED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARISOPRODOLCARISOPRODOLTABLET;ORAL350MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040245-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA1997-09-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040245-001AA

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-083f01610625f2…
2019-09-15 20:21 UTC2019-09A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A040245-001CARISOPRODOL350MGTABLET / ORAL1997-09-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040245-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040245-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040245-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040245-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040245-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040245-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040245-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040245-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040245-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040245-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040245-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040245-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040245-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040245-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040245-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040245-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040245-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040245-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040245-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040245-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040245-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040245-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040245-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040245-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040245-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040245-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040245-001AA1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040245-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040245-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040245-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040245-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040245-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040245-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040245-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040245-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040245-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040245-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040245-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040245-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040245-001AA1cb3db0bc1861…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarisoprodolCARISOPRODOLChartwell RX, LLCa44a3dfc-a427-4584-a086-4bc0c538b1252025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040245
application number: ANDA040245
ndc (product): 62135-241

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-2582CarisoprodolCarisoprodolPar PharmaceuticalANDACurrent
10544-033CarisoprodolCarisoprodolBlenheim Pharmacal, Inc.ANDACurrent
43063-302CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-064CarisoprodolCarisoprodolLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-2530CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
50090-2771CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
50436-2582CarisoprodolCarisoprodolUnit Dose ServicesANDACurrent
50436-2582CarisoprodolCarisoprodolUnit Dose ServicesANDACurrent
55045-1433CarisoprodolCarisoprodolDispensing Solutions, Inc.ANDACurrent
55700-836CarisoprodolCarisoprodolQuality Care Products, LLCANDACurrent
58657-645CarisoprodolCarisoprodolMethod Pharmaceuticals, LLCANDACurrent
58657-645CarisoprodolCarisoprodolMethod Pharmaceuticals, LLCANDACurrent
62135-241CarisoprodolCarisoprodolChartwell RX, LLCANDACurrent
63187-468CarisoprodolCarisoprodolProficient Rx LPANDACurrent
63187-468CarisoprodolCarisoprodolProficient Rx LPANDACurrent
63629-1167CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
63629-1167CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
63629-1168CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
63629-1168CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
63629-1169CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
63629-1169CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
63629-1308CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
63629-1308CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
63739-049CarisoprodolCarisoprodolMcKesson CorporationANDACurrent
63739-049CarisoprodolCarisoprodolMcKesson Corporation dba SKY PackagingANDACurrent
66336-635CarisoprodolCarisoprodolDispensing Solutions, Inc.ANDACurrent
67046-911CarisoprodolCarisoprodolContract Pharmacy Services-PAANDACurrent
67296-0271CarisoprodolCarisoprodolRedPharm Drug Inc.ANDACurrent
67544-012CarisoprodolCarisoprodolAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-2582CarisoprodolCarisoprodolPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0704CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
70518-0704CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
70518-1092CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
70518-1092CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
70518-3131CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
71610-430CarisoprodolCarisoprodolAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-531CarisoprodolCarisoprodolAphena Pharma Solutions - Tennessee, LLCANDACurrent
72789-016CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-016CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-016CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-016CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-016CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-019CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-019CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-019CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-019CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent