FDA.reportPublic FDA data

Cyclobenzaprine HCL

Product NDC
85509-1001
11-digit product format
855091001
Labeler code
85509
Product ID
85509-1001_488202dc-28f3-ad46-e063-6294a90a4238
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA078722
Marketing category
ANDA
Marketing start
2015-03-25
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 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 HCL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299

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
85509-1001-1Cyclobenzaprine HCL120 in 1 BOTTLETABLET, FILM COATED1202
85509-1001-3Cyclobenzaprine HCL30 in 1 BOTTLETABLET, FILM COATED302
85509-1001-6Cyclobenzaprine HCL60 in 1 BOTTLETABLET, FILM COATED602
85509-1001-9Cyclobenzaprine HCL90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1001-1EA - Each85509-100128522ea1-ab13-471d-8dbc-728cefe3de1412025-09-12
85509-1001-3EA - Each85509-1001bb8bece2-242a-4473-816b-c5dcd4acbe2212025-09-12
85509-1001-6EA - Each85509-100112fefb56-7807-47b3-be63-4b7cb0931ed312025-09-12
85509-1001-9EA - Each85509-100144e90feb-0a42-423d-89ca-676e3078da5612025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN3a397e88-d267-feed-e063-6294a90a77102
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD3a397e88-d267-feed-e063-6294a90a77102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1001-185509100101120 TABLET, FILM COATED in 1 BOTTLE (85509-1001-1) 2025-07-21NoNoHistorical
85509-1001-38550910010330 TABLET, FILM COATED in 1 BOTTLE (85509-1001-3) 2025-07-21NoNoHistorical
85509-1001-68550910010660 TABLET, FILM COATED in 1 BOTTLE (85509-1001-6) 2025-07-21NoNoHistorical
85509-1001-98550910010990 TABLET, FILM COATED in 1 BOTTLE (85509-1001-9) 2025-07-21NoNoHistorical