Carisoprodol Tablets, USP, 350 mg

Product NDC
63561-0127
11-digit product format
635610127
Labeler code
63561
Product ID
63561-0127_37394c09-4ae3-400c-e063-6294a90a65d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Granulation Technology, Inc.
Application
ANDA211789
Marketing category
ANDA
Marketing start
2025-06-11
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
63561-0127-1Carisoprodol Tablets, USP, 350 mg100 in 1 BOTTLE, PLASTICTABLET1002
63561-0127-2Carisoprodol Tablets, USP, 350 mg1000 in 1 BOTTLE, PLASTICTABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63561-0127CARISOPRODOL TABLETS, USP, 350 MG (CARISOPRODOL) TABLET [GRANULATION TECHNOLOGY, INC.]1Current NDC, 2 package rows20240310_2abd11e4-8ce4-4aeb-87c4-3af94c197714.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN409b04af-b9fd-4ba5-afa0-3e43466f8d2d101
197446carisoprodol 350 MG Oral TabletSCD409b04af-b9fd-4ba5-afa0-3e43466f8d2d101
197446carisoprodol 350 MG Oral TabletPSN35a8e0a4-93a3-44e3-903f-4661ee1cffe8100
197446carisoprodol 350 MG Oral TabletSCD35a8e0a4-93a3-44e3-903f-4661ee1cffe8100
197446carisoprodol 350 MG Oral TabletPSN1f08f4af-37c2-49b5-a4e3-284414f866fa6
197446carisoprodol 350 MG Oral TabletSCD1f08f4af-37c2-49b5-a4e3-284414f866fa6
197446carisoprodol 350 MG Oral TabletPSN2abd11e4-8ce4-4aeb-87c4-3af94c1977142
197446carisoprodol 350 MG Oral TabletSCD2abd11e4-8ce4-4aeb-87c4-3af94c1977142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63561-0127-163561012701100 TABLET in 1 BOTTLE, PLASTIC (63561-0127-1) 100 tablet2025-06-11NoNoCurrent
63561-0127-2635610127021000 TABLET in 1 BOTTLE, PLASTIC (63561-0127-2) 1000 tablet2025-06-11NoNoCurrent