FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
33342-272
11-digit product format
333420272
Labeler code
33342
Product ID
33342-272_fdf0f180-267f-434b-82f8-50c0a528d50c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA207314
Marketing category
ANDA
Marketing start
2024-07-22
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828353, 828358

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-272-09Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
33342-272-12Cyclobenzaprine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE102
33342-272-12Cyclobenzaprine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-272CYCLOBENZAPRINE CYCLOBENZAPRINE (CYCLOBENZAPRINE) CAPSULE [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 3 package rows20240808_1af467cb-7b21-4084-bb54-4634e928b167.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN1af467cb-7b21-4084-bb54-4634e928b1672
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSN1af467cb-7b21-4084-bb54-4634e928b1672
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD1af467cb-7b21-4084-bb54-4634e928b1672
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCD1af467cb-7b21-4084-bb54-4634e928b1672
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY1af467cb-7b21-4084-bb54-4634e928b1672
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY1af467cb-7b21-4084-bb54-4634e928b1672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-272-093334202720960 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-272-09) 2024-07-22NoNoCurrent
33342-272-123334202721210 BLISTER PACK in 1 CARTON (33342-272-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2024-07-22NoNoCurrent