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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
21925K482HCARISOPRODOL78-44-4CARISOPRODOL

Packages

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

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Carisoprodol Tablets, USP, 350 mgPD-Rx Pharmaceuticals, Inc.2025-10-23HUMAN PRESCRIPTION DRUG LABEL6
Carisoprodol Tablets, USP, 350 mgPD-Rx Pharmaceuticals, Inc.2025-09-16HUMAN PRESCRIPTION DRUG LABEL5