CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
85766-041
11-digit product format
857660041
Labeler code
85766
Product ID
85766-041_4e91823d-9f37-5437-e063-6294a90a0cd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sportpharm LLC
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
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 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
85766-041-00CYCLOBENZAPRINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10003
85766-041-01CYCLOBENZAPRINE HYDROCHLORIDE1 in 1 BOTTLETABLET, FILM COATED13
85766-041-02CYCLOBENZAPRINE HYDROCHLORIDE2 in 1 BOTTLETABLET, FILM COATED23
85766-041-03CYCLOBENZAPRINE HYDROCHLORIDE3 in 1 BOTTLETABLET, FILM COATED33
85766-041-04CYCLOBENZAPRINE HYDROCHLORIDE4 in 1 BOTTLETABLET, FILM COATED43
85766-041-05CYCLOBENZAPRINE HYDROCHLORIDE5 in 1 BOTTLETABLET, FILM COATED53
85766-041-07CYCLOBENZAPRINE HYDROCHLORIDE7 in 1 BOTTLETABLET, FILM COATED73
85766-041-09CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED103
85766-041-10CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1003
85766-041-14CYCLOBENZAPRINE HYDROCHLORIDE14 in 1 BOTTLETABLET, FILM COATED143
85766-041-15CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED153
85766-041-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED203
85766-041-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED303
85766-041-50CYCLOBENZAPRINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5003
85766-041-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED603
85766-041-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN24653b10-bdf0-47c5-a1f4-dc25f3b860323
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD24653b10-bdf0-47c5-a1f4-dc25f3b860323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-041-00857660041001000 TABLET, FILM COATED in 1 BOTTLE (85766-041-00) 2025-08-13NoNoHistorical
85766-041-01857660041011 TABLET, FILM COATED in 1 BOTTLE (85766-041-01) 2025-08-13NoNoHistorical
85766-041-02857660041022 TABLET, FILM COATED in 1 BOTTLE (85766-041-02) 2025-08-13NoNoHistorical
85766-041-03857660041033 TABLET, FILM COATED in 1 BOTTLE (85766-041-03) 2026-04-03NoNoHistorical
85766-041-04857660041044 TABLET, FILM COATED in 1 BOTTLE (85766-041-04) 2025-08-13NoNoHistorical
85766-041-05857660041055 TABLET, FILM COATED in 1 BOTTLE (85766-041-05) 2025-08-13NoNoHistorical
85766-041-07857660041077 TABLET, FILM COATED in 1 BOTTLE (85766-041-07) 2025-08-13NoNoHistorical
85766-041-098576600410910 TABLET, FILM COATED in 1 BOTTLE (85766-041-09) 2026-04-03NoNoHistorical
85766-041-1085766004110100 TABLET, FILM COATED in 1 BOTTLE (85766-041-10) 2025-08-13NoNoHistorical
85766-041-148576600411414 TABLET, FILM COATED in 1 BOTTLE (85766-041-14) 2025-08-13NoNoHistorical
85766-041-158576600411515 TABLET, FILM COATED in 1 BOTTLE (85766-041-15) 2025-08-13NoNoHistorical
85766-041-208576600412020 TABLET, FILM COATED in 1 BOTTLE (85766-041-20) 2025-08-13NoNoHistorical
85766-041-308576600413030 TABLET, FILM COATED in 1 BOTTLE (85766-041-30) 2025-08-13NoNoHistorical
85766-041-5085766004150500 TABLET, FILM COATED in 1 BOTTLE (85766-041-50) 2025-08-13NoNoHistorical
85766-041-608576600416060 TABLET, FILM COATED in 1 BOTTLE (85766-041-60) 2025-08-13NoNoHistorical
85766-041-908576600419090 TABLET, FILM COATED in 1 BOTTLE (85766-041-90) 2025-08-13NoNoHistorical