FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
71205-356
11-digit product format
712050356
Labeler code
71205
Product ID
71205-356_b8f42c39-b984-478f-a2b8-97209a356960
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
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828320

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
71205-356-15CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED155
71205-356-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED205
71205-356-21CYCLOBENZAPRINE HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED215
71205-356-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED305
71205-356-40CYCLOBENZAPRINE HYDROCHLORIDE40 in 1 BOTTLETABLET, FILM COATED405
71205-356-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED605
71205-356-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-356-15EA - Each71205-3569f3f7230-f0e5-40d1-a551-cdb301bf1cfb12021-10-08
71205-356-21EA - Each71205-356e613584d-aa0f-4a71-866a-c8970546c15e12023-08-08
71205-356-40EA - Each71205-356bad0c79f-c21b-4dfd-923a-bf56355f2fd312024-04-05
71205-356-60EA - Each71205-3562991fc55-9afa-4daa-9356-238ce5461a3812020-01-03
71205-356-90EA - Each71205-356c4e11832-d199-4310-b2b7-77e545bcf11b12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-356CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 7 package rows20240111_34ff8a08-0177-451f-9dbc-e21582346196.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN34ff8a08-0177-451f-9dbc-e215823461965
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD34ff8a08-0177-451f-9dbc-e215823461965

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-356-157120503561515 TABLET, FILM COATED in 1 BOTTLE (71205-356-15) 2021-07-200000-00-00NoNoCurrent
71205-356-207120503562020 TABLET, FILM COATED in 1 BOTTLE (71205-356-20) 2023-04-06NoNoCurrent
71205-356-217120503562121 TABLET, FILM COATED in 1 BOTTLE (71205-356-21) 2023-04-06NoNoCurrent
71205-356-307120503563030 TABLET, FILM COATED in 1 BOTTLE (71205-356-30) 2019-11-010000-00-00NoNoCurrent
71205-356-407120503564040 TABLET, FILM COATED in 1 BOTTLE (71205-356-40) 2024-01-08NoNoCurrent
71205-356-607120503566060 TABLET, FILM COATED in 1 BOTTLE (71205-356-60) 2019-11-010000-00-00NoNoCurrent
71205-356-907120503569090 TABLET, FILM COATED in 1 BOTTLE (71205-356-90) 2019-11-010000-00-00NoNoCurrent