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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
780d53a1-1665-e26e-d112-85333c0c8a2eProduct name520220516
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68387-600-122019-10-29C16284748780-1960f7f55-cdbb-8e05-e053-dbdaa90a074aThese 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
68387-600-152019-10-29C16284748780-1960f7f55-cdbb-8e05-e053-dbdaa90a074aThese 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
68387-600-302019-10-29C16284748780-1960f7f55-cdbb-8e05-e053-dbdaa90a074aThese 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
68387-600-452019-10-29C16284748780-1960f7f55-cdbb-8e05-e053-dbdaa90a074aThese 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
68387-600-602019-10-29C16284748780-1960f7f55-cdbb-8e05-e053-dbdaa90a074aThese 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
68387-600-902019-10-29C16284748780-1960f7f55-cdbb-8e05-e053-dbdaa90a074aThese 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 NDCProductDescriptionFormQuantityStrengthSPL version
68387-600-12Carisoprodol120 in 1 BOTTLE, PLASTICTABLET1205
68387-600-15Carisoprodol15 in 1 BOTTLE, PLASTICTABLET155
68387-600-30Carisoprodol30 in 1 BOTTLE, PLASTICTABLET305
68387-600-45Carisoprodol45 in 1 BOTTLE, PLASTICTABLET455
68387-600-60Carisoprodol60 in 1 BOTTLE, PLASTICTABLET605
68387-600-90Carisoprodol90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-600-12EA - Each68387-600b8f49f6a-7dc5-4902-8c34-553643fe293b12012-07-24
68387-600-15EA - Each68387-60011e03e58-d085-45d4-8215-f12409c3236112012-07-24
68387-600-30EA - Each68387-60049d299f4-0496-45f4-bbce-d9b47ac6194f12012-07-24
68387-600-45EA - Each68387-60025a0e9b6-ca30-47ec-a446-5d9076bf0d6b12012-07-24
68387-600-60EA - Each68387-6002e4ba91b-9e99-4187-ba65-3bfcd52311ce12012-07-24
68387-600-90EA - Each68387-600bc630fa5-1520-49ab-9c59-a83e914a5c2412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARISOPRODOLACTIVE INGREDIENT21925K482HCARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5
CARISOPRODOLACTIVE MOIETY21925K482HCARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JCARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-600CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]5Legacy NDC, 6 package rows20110118_9e517e32-d5ac-438d-b613-306e6aa6c45b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN9e517e32-d5ac-438d-b613-306e6aa6c45b5
197446carisoprodol 350 MG Oral TabletSCD9e517e32-d5ac-438d-b613-306e6aa6c45b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-600-1268387060012120 in 1 BOTTLE, PLASTICHistorical
68387-600-156838706001515 in 1 BOTTLE, PLASTICHistorical
68387-600-306838706003030 in 1 BOTTLE, PLASTICHistorical
68387-600-456838706004545 in 1 BOTTLE, PLASTICHistorical
68387-600-606838706006060 in 1 BOTTLE, PLASTICHistorical
68387-600-906838706009090 in 1 BOTTLE, PLASTICHistorical