Home NDC 68387-600 Carisoprodol
Product NDC 68387-600
11-digit product format 683870600
Labeler code 68387
Product ID 68387-600_ec7bacfe-34c8-48a0-b064-fc9367b81150
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carisoprodol
Dosage form TABLET
Route ORAL
Labeler Keltman Pharmaceuticals Inc.
Application ANDA040124
Marketing category ANDA
Marketing start 2007-08-10
Marketing end 0000-00-00
Substance CARISOPRODOL
Active strength 350 mg/1
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 154 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 A040124-001 CARISOPRODOL CARISOPRODOL 350MG TABLET / ORAL 1996-01-24
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 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040124-001 CARISOPRODOL 350MG TABLET / ORAL AA 1996-01-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040124-001 CARISOPRODOL 350MG TABLET / ORAL AA 1996-01-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040124-001 CARISOPRODOL 350MG TABLET / ORAL AA 1996-01-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040124-001 CARISOPRODOL 350MG TABLET / ORAL AA 1996-01-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040124-001 CARISOPRODOL 350MG TABLET / ORAL 1996-01-24 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 68387-600-12 These highlights do not include all the information needed to use Carisoprodol Tablets, USP safely and effectively. See full prescribing information for Carisoprodol Tablets, USP. Carisoprodol Tablets for Oral use Initial U.S. Approval: 1959 68387-600-15 These highlights do not include all the information needed to use Carisoprodol Tablets, USP safely and effectively. See full prescribing information for Carisoprodol Tablets, USP. Carisoprodol Tablets for Oral use Initial U.S. Approval: 1959 68387-600-30 These highlights do not include all the information needed to use Carisoprodol Tablets, USP safely and effectively. See full prescribing information for Carisoprodol Tablets, USP. Carisoprodol Tablets for Oral use Initial U.S. Approval: 1959 68387-600-45 These highlights do not include all the information needed to use Carisoprodol Tablets, USP safely and effectively. See full prescribing information for Carisoprodol Tablets, USP. Carisoprodol Tablets for Oral use Initial U.S. Approval: 1959 68387-600-60 These highlights do not include all the information needed to use Carisoprodol Tablets, USP safely and effectively. See full prescribing information for Carisoprodol Tablets, USP. Carisoprodol Tablets for Oral use Initial U.S. Approval: 1959 68387-600-90 These highlights do not include all the information needed to use Carisoprodol Tablets, USP safely and effectively. See full prescribing information for Carisoprodol Tablets, USP. Carisoprodol Tablets for Oral use Initial U.S. Approval: 1959
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68387-600-12 Carisoprodol 120 in 1 BOTTLE, PLASTIC TABLET 120 5 68387-600-15 Carisoprodol 15 in 1 BOTTLE, PLASTIC TABLET 15 5 68387-600-30 Carisoprodol 30 in 1 BOTTLE, PLASTIC TABLET 30 5 68387-600-45 Carisoprodol 45 in 1 BOTTLE, PLASTIC TABLET 45 5 68387-600-60 Carisoprodol 60 in 1 BOTTLE, PLASTIC TABLET 60 5 68387-600-90 Carisoprodol 90 in 1 BOTTLE, PLASTIC TABLET 90 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68387-600 CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.] 5 Legacy NDC, 6 package rows 20110118_9e517e32-d5ac-438d-b613-306e6aa6c45b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68387-600-12 68387060012 120 in 1 BOTTLE, PLASTIC Historical 68387-600-15 68387060015 15 in 1 BOTTLE, PLASTIC Historical 68387-600-30 68387060030 30 in 1 BOTTLE, PLASTIC Historical 68387-600-45 68387060045 45 in 1 BOTTLE, PLASTIC Historical 68387-600-60 68387060060 60 in 1 BOTTLE, PLASTIC Historical 68387-600-90 68387060090 90 in 1 BOTTLE, PLASTIC Historical