FDA.reportPublic FDA data

Carisoprodol

Product NDC
80425-0291
11-digit product format
804250291
Labeler code
80425
Product ID
80425-0291_2a9bf7d3-46d8-0dfa-e063-6394a90a76a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA203374
Marketing category
ANDA
Marketing start
2023-03-31
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
80425-0291-1Carisoprodol30 in 1 BOTTLETABLET302
80425-0291-2Carisoprodol60 in 1 BOTTLETABLET602
80425-0291-3Carisoprodol90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0291-1EA - Each80425-029176526813-f053-4983-b076-62adff12a47f12023-06-06
80425-0291-2EA - Each80425-02913331c05f-521a-481e-8cdb-6b5daf70a45a12023-06-06
80425-0291-3EA - Each80425-029144797d90-e08b-49f9-aa4f-729c33f84f5412023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0291CARISOPRODOL TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f835e66e-f3f3-c3cf-e053-6294a90addf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSNf835e66e-f3f3-c3cf-e053-6294a90addf22
197446carisoprodol 350 MG Oral TabletSCDf835e66e-f3f3-c3cf-e053-6294a90addf22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0291-18042502910130 TABLET in 1 BOTTLE (80425-0291-1) 30 tablet2023-03-31NoNoCurrent
80425-0291-28042502910260 TABLET in 1 BOTTLE (80425-0291-2) 60 tablet2023-03-31NoNoCurrent
80425-0291-38042502910390 TABLET in 1 BOTTLE (80425-0291-3) 90 tablet2023-03-31NoNoCurrent