Home NDC 53217-152 Carisoprodol
Product NDC 53217-152
11-digit product format 532170152
Labeler code 53217
Product ID 53217-152_8cc17b6d-c863-4b8e-ab32-c6c2b4c35d99
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carisoprodol
Dosage form TABLET
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA087499
Marketing category ANDA
Marketing start 1987-11-01
Marketing end 0000-00-00
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 2019-12-31
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 3 · 168 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A087499-001 CARISOPRODOL CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087499-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087499-001 CARISOPRODOL 350MG TABLET / ORAL AA 1982-04-20 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A087499-001 AA 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087499-001 AA 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A087499-001 AA 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A087499-001 AA 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 53217-152-02 These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959 53217-152-08 These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959 53217-152-16 These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959 53217-152-30 These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959 53217-152-45 These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959 53217-152-60 These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959 53217-152-90 These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53217-152 CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 7 package rows 20170302_f01e2d9f-3f1f-4220-8b79-077eeb9ac389.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53217-152-02 53217015202 120 in 1 BOTTLE Historical 53217-152-08 53217015208 08 in 1 BOTTLE Historical 53217-152-16 53217015216 16 in 1 BOTTLE Historical 53217-152-30 53217015230 30 in 1 BOTTLE Historical 53217-152-45 53217015245 45 in 1 BOTTLE Historical 53217-152-60 53217015260 60 in 1 BOTTLE Historical 53217-152-90 53217015290 90 in 1 BOTTLE Historical