FDA.reportPublic FDA data

Carisoprodol

Product NDC
71205-704
11-digit product format
712050704
Labeler code
71205
Product ID
71205-704_b04fbd67-9ac5-4043-87e9-c3804d1e5d0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040188
Marketing category
ANDA
Marketing start
2020-01-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
71205-704-30Carisoprodol30 in 1 BOTTLETABLET301
71205-704-60Carisoprodol60 in 1 BOTTLETABLET601
71205-704-90Carisoprodol90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-704-90EA - Each71205-70436799a75-9c6b-4093-9860-87a1df25ccc712022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-704CARISOPRODOL TABLET [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20221005_b04fbd67-9ac5-4043-87e9-c3804d1e5d0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSNb04fbd67-9ac5-4043-87e9-c3804d1e5d0c1
197446carisoprodol 350 MG Oral TabletSCDb04fbd67-9ac5-4043-87e9-c3804d1e5d0c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-704-307120507043030 TABLET in 1 BOTTLE (71205-704-30) 30 tablet2022-10-030000-00-00NoNoCurrent
71205-704-607120507046060 TABLET in 1 BOTTLE (71205-704-60) 60 tablet2022-10-030000-00-00NoNoCurrent
71205-704-907120507049090 TABLET in 1 BOTTLE (71205-704-90) 90 tablet2022-10-030000-00-00NoNoCurrent