FDA.reportPublic FDA data

Carisoprodol

Product NDC
71610-617
11-digit product format
716100617
Labeler code
71610
Product ID
71610-617_71d51e86-d125-48bc-8c1a-0f08ed9d547e
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
71610-617-30Carisoprodol30 in 1 BOTTLE, PLASTICTABLET301
71610-617-53Carisoprodol60 in 1 BOTTLE, PLASTICTABLET601
71610-617-60Carisoprodol90 in 1 BOTTLE, PLASTICTABLET901
71610-617-70Carisoprodol120 in 1 BOTTLE, PLASTICTABLET1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-617-30EA - Each71610-617ad14ecad-4c45-453d-a256-4f62fe02a69e12022-01-06
71610-617-53EA - Each71610-617dd9da5c2-68ee-4ac6-b81d-011fccc889d412022-01-06
71610-617-60EA - Each71610-617616a6114-c5dd-467d-84b7-d5e46f7b314212022-01-06
71610-617-70EA - Each71610-61703a3849e-82f9-481f-a216-5f5b21bad4de12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-617CARISOPRODOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 4 package rows20211214_2179f18b-df15-4bf6-a7c7-6d9960f49a42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN2179f18b-df15-4bf6-a7c7-6d9960f49a421
197446carisoprodol 350 MG Oral TabletSCD2179f18b-df15-4bf6-a7c7-6d9960f49a421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-617-307161006173030 TABLET in 1 BOTTLE, PLASTIC (71610-617-30) 30 tablet2021-11-240000-00-00NoNoCurrent
71610-617-537161006175360 TABLET in 1 BOTTLE, PLASTIC (71610-617-53) 60 tablet2021-11-240000-00-00NoNoCurrent
71610-617-607161006176090 TABLET in 1 BOTTLE, PLASTIC (71610-617-60) 90 tablet2021-11-240000-00-00NoNoCurrent
71610-617-7071610061770120 TABLET in 1 BOTTLE, PLASTIC (71610-617-70) 120 tablet2021-11-240000-00-00NoNoCurrent