FDA.reportPublic FDA data

Carisoprodol

Product NDC
72789-190
11-digit product format
727890190
Labeler code
72789
Product ID
72789-190_2d6a0cc6-8c41-6b0a-e063-6394a90a0c11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
72789-190-14Carisoprodol14 in 1 BOTTLE, PLASTICTABLET148
72789-190-30Carisoprodol30 in 1 BOTTLE, PLASTICTABLET308
72789-190-98Carisoprodol120 in 1 BOTTLE, PLASTICTABLET1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-190-14EA - Each72789-190a11918ec-908e-4cf7-9b50-ac8697d23e2212021-07-15
72789-190-30EA - Each72789-19035030ca8-d7f4-4817-8e15-c65a76dc7c5712021-07-15
72789-190-98EA - Each72789-19049a5eb58-f9c2-48eb-9f47-adf8536b105b12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-190CARISOPRODOL TABLET [PD-RX PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 3 package rows20250207_9d251c26-c893-425a-b8ac-20c06e50e80c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN9d251c26-c893-425a-b8ac-20c06e50e80c8
197446carisoprodol 350 MG Oral TabletSCD9d251c26-c893-425a-b8ac-20c06e50e80c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-190-147278901901414 TABLET in 1 BOTTLE, PLASTIC (72789-190-14) 14 tablet2021-05-260000-00-00NoNoCurrent
72789-190-307278901903030 TABLET in 1 BOTTLE, PLASTIC (72789-190-30) 30 tablet2021-05-200000-00-00NoNoCurrent
72789-190-9872789019098120 TABLET in 1 BOTTLE, PLASTIC (72789-190-98) 120 tablet2022-08-030000-00-00NoNoCurrent