FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
71205-065
11-digit product format
712050065
Labeler code
71205
Product ID
71205-065_7cb81f85-9453-48a6-a1dd-ac81e2de0dba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828348

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
71205-065-10CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED106
71205-065-12CYCLOBENZAPRINE HYDROCHLORIDE12 in 1 BOTTLETABLET, FILM COATED126
71205-065-15CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED156
71205-065-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED206
71205-065-21CYCLOBENZAPRINE HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED216
71205-065-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED306
71205-065-45CYCLOBENZAPRINE HYDROCHLORIDE45 in 1 BOTTLETABLET, FILM COATED456
71205-065-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED606
71205-065-72CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1206
71205-065-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-065-10EA - Each71205-065c57eba26-f748-4e0b-93cb-7265316bb73512018-10-11
71205-065-15EA - Each71205-065bf8cfce2-ad81-4fb0-858d-05e5a6c1a01d12018-10-11
71205-065-20EA - Each71205-0651b989521-5b9c-4b49-aab4-8e4f6a8b3c0812018-10-11
71205-065-21EA - Each71205-065e7597f8f-ab00-4495-9f1a-32e7e0e3533012018-10-11
71205-065-30EA - Each71205-0650c6f94eb-c400-4e8c-b76c-8c622dcb8f7b12018-10-11
71205-065-45EA - Each71205-06515f4e3bb-ca99-4e16-a025-3253ac9df48312018-10-11
71205-065-60EA - Each71205-06560755903-cfc9-4002-b1a2-566f792e136612018-10-11
71205-065-72EA - Each71205-0656cadc37e-e43e-4ecb-ae8a-db8c6d20c85412018-10-11
71205-065-90EA - Each71205-065efded8d2-ec5c-4c2c-ade4-54c9216570a612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-065CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 10 package rows20230907_88bdee56-d6d9-4f14-be77-1e6898ba36f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN88bdee56-d6d9-4f14-be77-1e6898ba36f56
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD88bdee56-d6d9-4f14-be77-1e6898ba36f56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-065-107120500651010 TABLET, FILM COATED in 1 BOTTLE (71205-065-10) 2018-07-020000-00-00NoNoCurrent
71205-065-127120500651212 TABLET, FILM COATED in 1 BOTTLE (71205-065-12) 2018-07-020000-00-00NoNoCurrent
71205-065-157120500651515 TABLET, FILM COATED in 1 BOTTLE (71205-065-15) 2018-07-020000-00-00NoNoCurrent
71205-065-207120500652020 TABLET, FILM COATED in 1 BOTTLE (71205-065-20) 2018-07-020000-00-00NoNoCurrent
71205-065-217120500652121 TABLET, FILM COATED in 1 BOTTLE (71205-065-21) 2018-07-020000-00-00NoNoCurrent
71205-065-307120500653030 TABLET, FILM COATED in 1 BOTTLE (71205-065-30) 2018-07-020000-00-00NoNoCurrent
71205-065-457120500654545 TABLET, FILM COATED in 1 BOTTLE (71205-065-45) 2018-07-020000-00-00NoNoCurrent
71205-065-607120500656060 TABLET, FILM COATED in 1 BOTTLE (71205-065-60) 2018-07-020000-00-00NoNoCurrent
71205-065-7271205006572120 TABLET, FILM COATED in 1 BOTTLE (71205-065-72) 2018-07-020000-00-00NoNoCurrent
71205-065-907120500659090 TABLET, FILM COATED in 1 BOTTLE (71205-065-90) 2018-07-020000-00-00NoNoCurrent