CARISOPRODOL

Product NDC
50228-109
11-digit product format
502280109
Labeler code
50228
Product ID
50228-109_60f38a99-69ef-4d7e-80b0-555575993116
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARISOPRODOL
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA203374
Marketing category
ANDA
Marketing start
2014-01-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CARISOPRODOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARISOPRODOL350 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii21925K482H
Rxcui197446

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-109-01CARISOPRODOL100 in 1 BOTTLETABLET1006
50228-109-05CARISOPRODOL500 in 1 BOTTLETABLET5006
50228-109-10CARISOPRODOL1000 in 1 BOTTLETABLET10006
50228-109-30CARISOPRODOL30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-109-01EA - Each50228-1099e4aebe7-8340-43fa-b8bd-0ffd48d0676d12019-03-12
50228-109-05EA - Each50228-1093f628e21-9992-4b09-9f2b-0d54ed4a595212019-03-12
50228-109-10EA - Each50228-109cc3dcff3-a435-4603-a09c-645b5e971d4412019-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARISOPRODOLACTIVE INGREDIENT21925K482HCARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]2
CARISOPRODOLACTIVE MOIETY21925K482HCARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-109CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20230108_069ea892-21a6-4703-8dd3-bf19c4406479.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSNa3f1343f-1337-4b99-b1ae-4189324ec2e9104
197446carisoprodol 350 MG Oral TabletPSN93f909ea-2d2e-4a10-be50-7f33f3e904d4104
197446carisoprodol 350 MG Oral TabletPSN59f6f0e3-fdbd-4788-9944-37edde4b9a3c104
197446carisoprodol 350 MG Oral TabletSCDa3f1343f-1337-4b99-b1ae-4189324ec2e9104
197446carisoprodol 350 MG Oral TabletSCD93f909ea-2d2e-4a10-be50-7f33f3e904d4104
197446carisoprodol 350 MG Oral TabletSCD59f6f0e3-fdbd-4788-9944-37edde4b9a3c104
197446carisoprodol 350 MG Oral TabletPSN269644bf-d32c-48a3-b3eb-1221150ebd22100
197446carisoprodol 350 MG Oral TabletSCD269644bf-d32c-48a3-b3eb-1221150ebd22100
197446carisoprodol 350 MG Oral TabletPSN069ea892-21a6-4703-8dd3-bf19c44064796
197446carisoprodol 350 MG Oral TabletPSNfdd6318f-399f-499c-acdc-5318aa080f366
197446carisoprodol 350 MG Oral TabletSCDfdd6318f-399f-499c-acdc-5318aa080f366
197446carisoprodol 350 MG Oral TabletSCD069ea892-21a6-4703-8dd3-bf19c44064796
197446carisoprodol 350 MG Oral TabletPSN8e9bb49a-8cc3-4390-e053-2a95a90a4e0e5
197446carisoprodol 350 MG Oral TabletSCD8e9bb49a-8cc3-4390-e053-2a95a90a4e0e5
197446carisoprodol 350 MG Oral TabletPSN2178e805-8189-459f-a447-21bf1547744a3
197446carisoprodol 350 MG Oral TabletPSN94f74800-1f0d-7814-e053-2a95a90a4f633
197446carisoprodol 350 MG Oral TabletPSN67f54a7d-e41d-420e-90f4-9c46d19de41c3
197446carisoprodol 350 MG Oral TabletPSN93cbe188-5443-b392-e053-2995a90a9ac73
197446carisoprodol 350 MG Oral TabletSCD94f74800-1f0d-7814-e053-2a95a90a4f633
197446carisoprodol 350 MG Oral TabletSCD2178e805-8189-459f-a447-21bf1547744a3
197446carisoprodol 350 MG Oral TabletSCD93cbe188-5443-b392-e053-2995a90a9ac73
197446carisoprodol 350 MG Oral TabletSCD67f54a7d-e41d-420e-90f4-9c46d19de41c3
197446carisoprodol 350 MG Oral TabletPSN26e466be-8066-e562-e063-6394a90a9f812
197446carisoprodol 350 MG Oral TabletPSNf835e66e-f3f3-c3cf-e053-6294a90addf22
197446carisoprodol 350 MG Oral TabletSCD26e466be-8066-e562-e063-6394a90a9f812
197446carisoprodol 350 MG Oral TabletSCDf835e66e-f3f3-c3cf-e053-6294a90addf22
197446carisoprodol 350 MG Oral TabletPSN8bdb858f-2c36-780f-e053-2995a90a3a221
197446carisoprodol 350 MG Oral TabletPSN4221d7d1-d7d6-46c4-be41-8c8e991293241
197446carisoprodol 350 MG Oral TabletPSN8a845530-8bec-f872-e053-2a95a90ad5301
197446carisoprodol 350 MG Oral TabletPSN9af17486-02ed-a54b-e053-2a95a90ad8b31
197446carisoprodol 350 MG Oral TabletPSNaa6aa4dd-70b1-d942-e053-2995a90a9cde1
197446carisoprodol 350 MG Oral TabletSCD4221d7d1-d7d6-46c4-be41-8c8e991293241
197446carisoprodol 350 MG Oral TabletSCD8bdb858f-2c36-780f-e053-2995a90a3a221
197446carisoprodol 350 MG Oral TabletSCD9af17486-02ed-a54b-e053-2a95a90ad8b31
197446carisoprodol 350 MG Oral TabletSCDaa6aa4dd-70b1-d942-e053-2995a90a9cde1
197446carisoprodol 350 MG Oral TabletSCD8a845530-8bec-f872-e053-2a95a90ad5301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-109-0150228010901100 TABLET in 1 BOTTLE (50228-109-01) 100 tablet2014-01-270000-00-00NoNoCurrent
50228-109-0550228010905500 TABLET in 1 BOTTLE (50228-109-05) 500 tablet2014-01-270000-00-00NoNoCurrent
50228-109-10502280109101000 TABLET in 1 BOTTLE (50228-109-10) 1000 tablet2014-01-270000-00-00NoNoCurrent
50228-109-305022801093030 TABLET in 1 BOTTLE (50228-109-30) 30 tablet2014-01-270000-00-00NoNoCurrent