FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
85509-1035
11-digit product format
855091035
Labeler code
85509
Product ID
85509-1035_48c33f75-b43a-b007-e063-6394a90a411e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA091281
Marketing category
ANDA
Marketing start
2019-03-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828358

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1035-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
85509-1035-6Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
85509-1035-9Cyclobenzaprine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN48c33e51-db07-af68-e063-6294a90a897e1
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD48c33e51-db07-af68-e063-6294a90a897e1
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY48c33e51-db07-af68-e063-6294a90a897e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1035-38550910350330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-3) 2026-01-19NoNoCurrent
85509-1035-68550910350660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-6) 2026-01-19NoNoCurrent
85509-1035-98550910350990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-9) 2026-01-19NoNoCurrent