Home NDC 0603-2582 Carisoprodol
Product NDC 0603-2582
11-digit product format 006032582
Labeler code 0603
Product ID 0603-2582_aea2d38d-5e40-4e65-a4c5-d4b6a43981cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carisoprodol
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical
Application ANDA040245
Marketing category ANDA
Marketing start 1997-09-08
Marketing end 2020-06-30
Substance CARISOPRODOL
Active strength 350 mg/1
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
DEA schedule CIV
NDC exclude flag No
Listing certified through 0000-00-00
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 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040245-001 CARISOPRODOL CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040245-001 AA
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040245-001 CARISOPRODOL 350MG TABLET / ORAL 1997-09-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040245-001 CARISOPRODOL 350MG TABLET / ORAL AA 1997-09-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARISOPRODOL ACTIVE INGREDIENT 21925K482H CARISOPRODOL TABLET [BRYANT RANCH PREPACK] 1000 CARISOPRODOL ACTIVE MOIETY 21925K482H CARISOPRODOL TABLET [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARISOPRODOL TABLET [BRYANT RANCH PREPACK] 1000 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARISOPRODOL TABLET [BRYANT RANCH PREPACK] 1000 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARISOPRODOL TABLET [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARISOPRODOL TABLET [BRYANT RANCH PREPACK] 1000 CARISOPRODOL ACTIVE INGREDIENT 21925K482H CARISOPRODOL TABLET [QUALITEST PHARMACEUTICALS] 18 CARISOPRODOL ACTIVE MOIETY 21925K482H CARISOPRODOL TABLET [QUALITEST PHARMACEUTICALS] 18 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARISOPRODOL TABLET [QUALITEST PHARMACEUTICALS] 18 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARISOPRODOL TABLET [QUALITEST PHARMACEUTICALS] 18 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARISOPRODOL TABLET [QUALITEST PHARMACEUTICALS] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARISOPRODOL TABLET [QUALITEST PHARMACEUTICALS] 18 CARISOPRODOL ACTIVE INGREDIENT 21925K482H CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 3 CARISOPRODOL ACTIVE INGREDIENT 21925K482H CARISOPRODOL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 CARISOPRODOL ACTIVE MOIETY 21925K482H CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 3 CARISOPRODOL ACTIVE MOIETY 21925K482H CARISOPRODOL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARISOPRODOL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARISOPRODOL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARISOPRODOL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARISOPRODOL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 3 CARISOPRODOL ACTIVE INGREDIENT 21925K482H CARISOPRODOL TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 CARISOPRODOL ACTIVE INGREDIENT 21925K482H CARISOPRODOL TABLET [REBEL DISTRIBUTORS CORP.] 2 CARISOPRODOL ACTIVE INGREDIENT 21925K482H CARISOPRODOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CARISOPRODOL ACTIVE MOIETY 21925K482H CARISOPRODOL TABLET [REBEL DISTRIBUTORS CORP.] 2 CARISOPRODOL ACTIVE MOIETY 21925K482H CARISOPRODOL TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 CARISOPRODOL ACTIVE MOIETY 21925K482H CARISOPRODOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARISOPRODOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARISOPRODOL TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARISOPRODOL TABLET [REBEL DISTRIBUTORS CORP.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARISOPRODOL TABLET [REBEL DISTRIBUTORS CORP.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARISOPRODOL TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARISOPRODOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO CARISOPRODOL TABLET [REBEL DISTRIBUTORS CORP.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARISOPRODOL TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARISOPRODOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARISOPRODOL TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARISOPRODOL TABLET [REBEL DISTRIBUTORS CORP.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARISOPRODOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CARISOPRODOL ACTIVE INGREDIENT 21925K482H CARISOPRODOL TABLET [REDPHARM DRUG INC.] 1 CARISOPRODOL ACTIVE INGREDIENT 21925K482H CARISOPRODOL TABLET [PROFICIENT RX LP] 1 CARISOPRODOL ACTIVE INGREDIENT 21925K482H CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.] 1 CARISOPRODOL ACTIVE INGREDIENT 21925K482H CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 1 CARISOPRODOL ACTIVE MOIETY 21925K482H CARISOPRODOL TABLET [REDPHARM DRUG INC.] 1 CARISOPRODOL ACTIVE MOIETY 21925K482H CARISOPRODOL TABLET [PROFICIENT RX LP] 1 CARISOPRODOL ACTIVE MOIETY 21925K482H CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 1 CARISOPRODOL ACTIVE MOIETY 21925K482H CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARISOPRODOL TABLET [REDPHARM DRUG INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARISOPRODOL TABLET [PROFICIENT RX LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARISOPRODOL TABLET [PROFICIENT RX LP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARISOPRODOL TABLET [REDPHARM DRUG INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARISOPRODOL TABLET [PROFICIENT RX LP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARISOPRODOL TABLET [REDPHARM DRUG INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARISOPRODOL TABLET [PROFICIENT RX LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARISOPRODOL TABLET [DISPENSING SOLUTIONS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARISOPRODOL TABLET [REDPHARM DRUG INC.] 1
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.
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