Carisoprodol Tablets, USP, 350 mg

Product NDC
72789-477
11-digit product format
727890477
Labeler code
72789
Product ID
72789-477_41d80caa-d146-cdc1-e063-6294a90a8dc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA211789
Marketing category
ANDA
Marketing start
2025-05-11
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 Tablets, USP, 350 mg
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
72789-477-01Carisoprodol Tablets, USP, 350 mg100 in 1 BOTTLE, PLASTICTABLET1006
72789-477-30Carisoprodol Tablets, USP, 350 mg30 in 1 BOTTLE, PLASTICTABLET306
72789-477-90Carisoprodol Tablets, USP, 350 mg90 in 1 BOTTLE, PLASTICTABLET906
72789-477-95Carisoprodol Tablets, USP, 350 mg1000 in 1 BOTTLE, PLASTICTABLET10006
72789-477-98Carisoprodol Tablets, USP, 350 mg120 in 1 BOTTLE, PLASTICTABLET1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-477-01EA - Each72789-4776ba71bc2-c12c-4090-bdd9-6feb3831af3a12025-03-04
72789-477-30EA - Each72789-47762fa752f-8176-4551-a8d6-9da9fcf82aff12025-12-16
72789-477-90EA - Each72789-477c4e506c8-ad07-4054-a8a2-f3b25cf01d6312025-09-12
72789-477-95EA - Each72789-477b3aed56f-47ca-4d88-8910-c5801e7d1bf312025-03-04
72789-477-98EA - Each72789-477bd971ed3-6e2e-4c0e-862d-dea2370afb1f12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-477CARISOPRODOL TABLETS, USP, 350 MG (CARISOPRODOL) TABLET [PD-RX PHARMACEUTICALS, INC.]2Current NDC, 5 package rows20250205_1f08f4af-37c2-49b5-a4e3-284414f866fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN1f08f4af-37c2-49b5-a4e3-284414f866fa6
197446carisoprodol 350 MG Oral TabletSCD1f08f4af-37c2-49b5-a4e3-284414f866fa6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-477-0172789047701100 TABLET in 1 BOTTLE, PLASTIC (72789-477-01) 100 tablet2025-05-11NoNoCurrent
72789-477-307278904773030 TABLET in 1 BOTTLE, PLASTIC (72789-477-30) 30 tablet2025-10-23NoNoCurrent
72789-477-907278904779090 TABLET in 1 BOTTLE, PLASTIC (72789-477-90) 90 tablet2025-08-06NoNoCurrent
72789-477-95727890477951000 TABLET in 1 BOTTLE, PLASTIC (72789-477-95) 1000 tablet2025-05-11NoNoCurrent
72789-477-9872789047798120 TABLET in 1 BOTTLE, PLASTIC (72789-477-98) 120 tablet2025-08-12NoNoCurrent