FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
72189-545
11-digit product format
721890545
Labeler code
72189
Product ID
72189-545_4c4c0bb8-ab70-3f03-e063-6294a90af0b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA208170
Marketing category
ANDA
Marketing start
2024-04-09
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
72189-545-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED154
72189-545-21Cyclobenzaprine Hydrochloride21 in 1 BOTTLETABLET, FILM COATED214
72189-545-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
72189-545-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
72189-545-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-545-15EA - Each72189-5457f0b4af4-9a89-4160-b020-732c29e049f412024-05-16
72189-545-30EA - Each72189-545e9ee3099-9515-4c35-9a9b-1d3deac528e412024-06-10
72189-545-60EA - Each72189-545d616b844-ddbd-459f-aaac-49595a3c94f312024-05-16
72189-545-90EA - Each72189-5458faa7586-2daf-46ae-8460-ad2d91677cae12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-545CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX]3Current NDC, 5 package rows20240509_15aad4af-5c05-be36-e063-6294a90a9bb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN15aad4af-5c05-be36-e063-6294a90a9bb34
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD15aad4af-5c05-be36-e063-6294a90a9bb34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-545-157218905451515 TABLET, FILM COATED in 1 BOTTLE (72189-545-15) 2024-04-09NoNoHistorical
72189-545-217218905452121 TABLET, FILM COATED in 1 BOTTLE (72189-545-21) 2024-04-09NoNoHistorical
72189-545-307218905453030 TABLET, FILM COATED in 1 BOTTLE (72189-545-30) 2024-04-09NoNoHistorical
72189-545-607218905456060 TABLET, FILM COATED in 1 BOTTLE (72189-545-60) 2024-04-09NoNoHistorical
72189-545-907218905459090 TABLET, FILM COATED in 1 BOTTLE (72189-545-90) 2024-04-09NoNoHistorical