Carisoprodol

Product NDC
52959-026
11-digit product format
529590026
Labeler code
52959
Product ID
52959-026_8baadcf8-d2c4-40c6-9fa0-485a0d699745
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA040124
Marketing category
ANDA
Marketing start
1996-01-24
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
E
Listing certified through
2018-12-31
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
52959-026-002020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-032020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-062020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-102020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-122020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-142020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-152020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-202020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-212020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-242020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-252020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-282020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-302020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-322020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-402020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-422020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-452020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-502020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-522020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-562020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-602020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-802020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
52959-026-902020-01-31C16284748780-19d75b9d0-87f1-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only Rev. 01/12 These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-026-30Prazolamine30 in 1 BOTTLETABLET30350 mg18
52959-026-00Carisoprodol100 in 1 BOTTLE, PLASTICTABLET1004
52959-026-03Carisoprodol120 in 1 BOTTLE, PLASTICTABLET1204
52959-026-06Carisoprodol06 in 1 BOTTLE, PLASTICTABLET064
52959-026-10Carisoprodol10 in 1 BOTTLE, PLASTICTABLET104
52959-026-12Carisoprodol12 in 1 BOTTLE, PLASTICTABLET124
52959-026-14Carisoprodol14 in 1 BOTTLE, PLASTICTABLET144
52959-026-15Carisoprodol15 in 1 BOTTLE, PLASTICTABLET154
52959-026-20Carisoprodol20 in 1 BOTTLE, PLASTICTABLET204
52959-026-21Carisoprodol21 in 1 BOTTLE, PLASTICTABLET214
52959-026-24Carisoprodol24 in 1 BOTTLE, PLASTICTABLET244
52959-026-25Carisoprodol25 in 1 BOTTLE, PLASTICTABLET254
52959-026-28Carisoprodol28 in 1 BOTTLE, PLASTICTABLET284
52959-026-30Carisoprodol30 in 1 BOTTLE, PLASTICTABLET304
52959-026-32Carisoprodol32 in 1 BOTTLE, PLASTICTABLET324
52959-026-40Carisoprodol40 in 1 BOTTLE, PLASTICTABLET404
52959-026-42Carisoprodol42 in 1 BOTTLE, PLASTICTABLET424
52959-026-45Carisoprodol45 in 1 BOTTLE, PLASTICTABLET454
52959-026-50Carisoprodol50 in 1 BOTTLE, PLASTICTABLET504
52959-026-52Carisoprodol52 in 1 BOTTLE, PLASTICTABLET524
52959-026-56Carisoprodol56 in 1 BOTTLE, PLASTICTABLET564
52959-026-60Carisoprodol60 in 1 BOTTLE, PLASTICTABLET604
52959-026-80Carisoprodol80 in 1 BOTTLE, PLASTICTABLET804
52959-026-90Carisoprodol90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-026-00EA - Each52959-026aa9e7613-0364-48e7-8472-596ec75b38a212012-07-24
52959-026-03EA - Each52959-0265b9256b5-547e-400b-b136-bf088e14c3f912012-07-24
52959-026-06EA - Each52959-026952d3d9f-2104-4488-8c8a-de0ed539ee7512012-07-24
52959-026-10EA - Each52959-02642ca42d0-6d81-434c-9414-eaef4871095e12012-07-24
52959-026-12EA - Each52959-0263aed03e1-abb6-4893-aed5-30892e84242912012-07-24
52959-026-14EA - Each52959-02631686109-9d91-4e87-b560-3520649f65e112012-07-24
52959-026-15EA - Each52959-026db540f51-ef3f-4ef4-95b5-f9bf0c09796e12012-07-24
52959-026-20EA - Each52959-026b9b15167-ec56-4bc1-b47e-633a2c61217212012-07-24
52959-026-21EA - Each52959-0262e58ba18-31d9-484b-8889-494165c08da412012-07-24
52959-026-24EA - Each52959-026e44bd27a-8517-41c2-9245-0f285e10c6ad12012-07-24
52959-026-25EA - Each52959-026e2c16149-679e-421f-99c0-a19022d8d8ed12012-07-24
52959-026-28EA - Each52959-0263547d6dd-50b8-4b51-ba13-057c10947bc112012-07-24
52959-026-30EA - Each52959-02616df71d0-31a5-41b2-b4d4-49ae32b1cd0b12012-07-24
52959-026-32EA - Each52959-026b8688fc1-1b49-4681-ac3d-f16ef3ed4ba912012-07-24
52959-026-40EA - Each52959-0264851b539-aea3-4ad3-87f0-8bb311d118d112012-07-24
52959-026-45EA - Each52959-026a6e8258c-6fce-42ea-85be-66c7be28277012012-07-24
52959-026-50EA - Each52959-0260a2fa3d2-8773-46d5-ba85-547f34fad34812012-07-24
52959-026-52EA - Each52959-026d23d85e1-beff-4c82-bdbe-c159fd50a88612012-07-24
52959-026-56EA - Each52959-0261cea57c5-1317-4e25-aa7c-42c63c23148912012-07-24
52959-026-60EA - Each52959-026c371f0b4-ec7a-4975-a862-f0f8dd42fadc12012-07-24
52959-026-80EA - Each52959-0261d24fb2e-ff7a-401d-8063-f4134eb2f87f12012-07-24
52959-026-90EA - Each52959-026b2ab64bb-d684-495a-8731-7be0826bcfcb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6IPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
CARISOPRODOLACTIVE INGREDIENT21925K482HPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6IPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
CARISOPRODOLACTIVE MOIETY21925K482HPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
GELATININACTIVE INGREDIENT2G86QN327LPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
POVIDONEINACTIVE INGREDIENTFZ989GH94EPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18
CARISOPRODOLACTIVE INGREDIENT21925K482HCARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4
CARISOPRODOLACTIVE MOIETY21925K482HCARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JCARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-026PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]18Legacy NDC20110812_99265e39-af23-43eb-a552-305f0a218fdf.zip
52959-026CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]4Legacy NDC, 23 package rows20120919_037618dc-8aed-4a96-93a5-69971f2a3742.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN99265e39-af23-43eb-a552-305f0a218fdf18
197446carisoprodol 350 MG Oral TabletSCD99265e39-af23-43eb-a552-305f0a218fdf18
197446carisoprodol 350 MG Oral TabletPSN037618dc-8aed-4a96-93a5-69971f2a37424
197446carisoprodol 350 MG Oral TabletSCD037618dc-8aed-4a96-93a5-69971f2a37424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-026-0052959002600100 in 1 BOTTLE, PLASTICHistorical
52959-026-0352959002603120 in 1 BOTTLE, PLASTICHistorical
52959-026-065295900260606 in 1 BOTTLE, PLASTICHistorical
52959-026-105295900261010 in 1 BOTTLE, PLASTICHistorical
52959-026-125295900261212 in 1 BOTTLE, PLASTICHistorical
52959-026-145295900261414 in 1 BOTTLE, PLASTICHistorical
52959-026-155295900261515 in 1 BOTTLE, PLASTICHistorical
52959-026-205295900262020 in 1 BOTTLE, PLASTICHistorical
52959-026-215295900262121 in 1 BOTTLE, PLASTICHistorical
52959-026-245295900262424 in 1 BOTTLE, PLASTICHistorical
52959-026-255295900262525 in 1 BOTTLE, PLASTICHistorical
52959-026-285295900262828 in 1 BOTTLE, PLASTICHistorical
52959-026-305295900263030 in 1 BOTTLEHistorical
52959-026-325295900263232 in 1 BOTTLE, PLASTICHistorical
52959-026-405295900264040 in 1 BOTTLE, PLASTICHistorical
52959-026-425295900264242 in 1 BOTTLE, PLASTICHistorical
52959-026-455295900264545 in 1 BOTTLE, PLASTICHistorical
52959-026-505295900265050 in 1 BOTTLE, PLASTICHistorical
52959-026-525295900265252 in 1 BOTTLE, PLASTICHistorical
52959-026-565295900265656 in 1 BOTTLE, PLASTICHistorical
52959-026-605295900266060 in 1 BOTTLE, PLASTICHistorical
52959-026-805295900268080 in 1 BOTTLE, PLASTICHistorical
52959-026-905295900269090 in 1 BOTTLE, PLASTICHistorical