FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
72603-310
11-digit product format
726030310
Labeler code
72603
Product ID
72603-310_4764d2fb-f80d-1435-e063-6294a90acd0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NORTHSTAR RX LLC
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
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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299, 828320, 828348

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
72603-310-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
72603-310-02Cyclobenzaprine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-310-01EA - Each72603-310fffe7684-8498-49cd-a29a-e7fbcd73e39712025-01-14
72603-310-02EA - Each72603-310fc45b7a6-67dc-436a-85d0-2ad6837c4c9912025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-310CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]1Current NDC, 2 package rows20241031_2a3a13c3-116c-4e9e-a7f3-7ad7c80486c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN2a3a13c3-116c-4e9e-a7f3-7ad7c80486c32
828320cyclobenzaprine HCl 5 MG Oral TabletPSN2a3a13c3-116c-4e9e-a7f3-7ad7c80486c32
828320cyclobenzaprine HCl 5 MG Oral TabletPSN43ce2c79-ec4a-5120-e063-6394a90af6e12
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN2a3a13c3-116c-4e9e-a7f3-7ad7c80486c32
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD2a3a13c3-116c-4e9e-a7f3-7ad7c80486c32
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD2a3a13c3-116c-4e9e-a7f3-7ad7c80486c32
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD43ce2c79-ec4a-5120-e063-6394a90af6e12
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD2a3a13c3-116c-4e9e-a7f3-7ad7c80486c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-310-0172603031001100 TABLET, FILM COATED in 1 BOTTLE (72603-310-01) 2024-11-01NoNoCurrent
72603-310-0272603031002500 TABLET, FILM COATED in 1 BOTTLE (72603-310-02) 2024-11-01NoNoCurrent