FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
55700-239
11-digit product format
557000239
Labeler code
55700
Product ID
55700-239_0498b9cc-1111-40b9-9605-08c32d167c7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA078722
Marketing category
ANDA
Marketing start
2015-03-25
Marketing end
2027-12-31
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride

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
55700-239-01Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED12012
55700-239-10Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED1012
55700-239-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3012
55700-239-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6012
55700-239-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-239-01EA - Each55700-239b2476a5e-77bb-481b-9ec6-c41aeed9303312016-12-07
55700-239-10EA - Each55700-2392687e04c-a6d3-44e6-941f-884561bdff0d12018-12-13
55700-239-30EA - Each55700-239d79697f4-6369-4e35-9bcd-6957e788637312016-12-07
55700-239-60EA - Each55700-239186f80cf-d6ca-4483-ab43-3d1a83af4e4b12016-12-07
55700-239-90EA - Each55700-23988a354c9-9334-4365-9e6d-5ecb9f92c42512016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-239CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [QUALITY CARE PRODUCTS LLC]12Current NDC, Legacy NDC, 5 package rows20241219_794d350b-6c88-41d5-b68b-3e2c57ee2a4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN794d350b-6c88-41d5-b68b-3e2c57ee2a4f12
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD794d350b-6c88-41d5-b68b-3e2c57ee2a4f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-239-0155700023901120 TABLET, FILM COATED in 1 BOTTLE (55700-239-01) 2015-04-240000-00-00NoNoCurrent
55700-239-105570002391010 in 1 BOTTLEHistorical
55700-239-305570002393030 TABLET, FILM COATED in 1 BOTTLE (55700-239-30) 2015-04-240000-00-00NoNoCurrent
55700-239-605570002396060 TABLET, FILM COATED in 1 BOTTLE (55700-239-60) 2022-04-080000-00-00NoNoCurrent
55700-239-905570002399090 TABLET, FILM COATED in 1 BOTTLE (55700-239-90) 2022-04-082027-12-31NoNoCurrent