FDA.reportPublic FDA data

Soma

Product NDC
0037-2250
11-digit product format
000372250
Labeler code
0037
Product ID
0037-2250_7272db18-d8cf-4bd0-ab9d-37e191a06f18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA011792
Marketing category
NDA
Marketing start
2007-09-08
Substance
CARISOPRODOL
Active strength
250 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Soma
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARISOPRODOL250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii21925K482H
Rxcui197446, 213695, 730794, 730918

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
0037-2250-10Soma100 in 1 BOTTLE, PLASTICTABLET10020
0037-2250-30Soma30 in 1 BOTTLE, PLASTICTABLET3020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0037-2250SOMA (CARISOPRODOL) TABLET [MEDA PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 2 package rows20230719_6297cf20-830a-11dc-94c8-0002a5d5c51b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
730794carisoprodol 250 MG Oral TabletPSN6297cf20-830a-11dc-94c8-0002a5d5c51b20
197446carisoprodol 350 MG Oral TabletPSN6297cf20-830a-11dc-94c8-0002a5d5c51b20
730918Soma 250 MG Oral TabletPSN6297cf20-830a-11dc-94c8-0002a5d5c51b20
213695Soma 350 MG Oral TabletPSN6297cf20-830a-11dc-94c8-0002a5d5c51b20
730918carisoprodol 250 MG Oral Tablet [Soma]SBD6297cf20-830a-11dc-94c8-0002a5d5c51b20
213695carisoprodol 350 MG Oral Tablet [Soma]SBD6297cf20-830a-11dc-94c8-0002a5d5c51b20
730794carisoprodol 250 MG Oral TabletSCD6297cf20-830a-11dc-94c8-0002a5d5c51b20
197446carisoprodol 350 MG Oral TabletSCD6297cf20-830a-11dc-94c8-0002a5d5c51b20
730918Soma 250 MG Oral TabletSY6297cf20-830a-11dc-94c8-0002a5d5c51b20
213695Soma 350 MG Oral TabletSY6297cf20-830a-11dc-94c8-0002a5d5c51b20
730794carisoprodol 250 MG Oral TabletPSN6543c6ba-852e-40fb-b7ec-1331b9c836561
730794carisoprodol 250 MG Oral TabletPSNb38e1880-9152-4ca4-93e3-b9f6d14db9581
730918Soma 250 MG Oral TabletPSN6543c6ba-852e-40fb-b7ec-1331b9c836561
730918Soma 250 MG Oral TabletPSNb38e1880-9152-4ca4-93e3-b9f6d14db9581
730918carisoprodol 250 MG Oral Tablet [Soma]SBD6543c6ba-852e-40fb-b7ec-1331b9c836561
730918carisoprodol 250 MG Oral Tablet [Soma]SBDb38e1880-9152-4ca4-93e3-b9f6d14db9581
730794carisoprodol 250 MG Oral TabletSCDb38e1880-9152-4ca4-93e3-b9f6d14db9581
730794carisoprodol 250 MG Oral TabletSCD6543c6ba-852e-40fb-b7ec-1331b9c836561
730918Soma 250 MG Oral TabletSY6543c6ba-852e-40fb-b7ec-1331b9c836561
730918Soma 250 MG Oral TabletSYb38e1880-9152-4ca4-93e3-b9f6d14db9581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0037-2250-1000037225010100 TABLET in 1 BOTTLE, PLASTIC (0037-2250-10) 100 tablet2007-09-080000-00-00NoNoCurrent
0037-2250-300003722503030 TABLET in 1 BOTTLE, PLASTIC (0037-2250-30) 30 tablet2007-09-080000-00-00NoNoCurrent