FDA.reportPublic FDA data

Carisoprodol

Product NDC
71610-761
11-digit product format
716100761
Labeler code
71610
Product ID
71610-761_27a52629-b6f7-4b68-a7ee-01a2175bf236
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
71610-761-30Carisoprodol30 in 1 BOTTLETABLET302
71610-761-53Carisoprodol60 in 1 BOTTLETABLET602
71610-761-60Carisoprodol90 in 1 BOTTLETABLET902
71610-761-70Carisoprodol120 in 1 BOTTLETABLET1202
71610-761-75Carisoprodol150 in 1 BOTTLETABLET1502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-761-30EA - Each71610-76122a86bee-f847-4a96-9b31-ffb35bba86a712024-02-14
71610-761-53EA - Each71610-76151da0e6b-3966-46c0-833b-006b02b6932012024-02-14
71610-761-60EA - Each71610-7614526a333-abbf-4d16-b3ad-db4f6211d5fb12024-02-14
71610-761-70EA - Each71610-761d49923d3-bea1-487c-8b92-fc45921be97b12024-02-14
71610-761-75EA - Each71610-7614ba8f4bd-5614-4d87-9480-4eeda2151bdd12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-761CARISOPRODOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 5 package rows20231212_2484de44-b36a-421c-a4d9-64c201694754.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN2484de44-b36a-421c-a4d9-64c2016947542
197446carisoprodol 350 MG Oral TabletSCD2484de44-b36a-421c-a4d9-64c2016947542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-761-307161007613030 TABLET in 1 BOTTLE (71610-761-30) 30 tablet2023-12-05NoNoCurrent
71610-761-537161007615360 TABLET in 1 BOTTLE (71610-761-53) 60 tablet2023-12-05NoNoCurrent
71610-761-607161007616090 TABLET in 1 BOTTLE (71610-761-60) 90 tablet2023-12-05NoNoCurrent
71610-761-7071610076170120 TABLET in 1 BOTTLE (71610-761-70) 120 tablet2023-12-05NoNoCurrent
71610-761-7571610076175150 TABLET in 1 BOTTLE (71610-761-75) 150 tablet2023-12-05NoNoCurrent