FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
76282-283
11-digit product format
762820283
Labeler code
76282
Product ID
76282-283_19cb705f-c529-4ad4-8eda-3a3fd48feca7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET
Route
ORAL
Labeler
EXELAN PHARMACEUTICALS, INC.
Application
ANDA090478
Marketing category
ANDA
Marketing start
2025-04-10
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
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 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
76282-283-10Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET10001
76282-283-18Cyclobenzaprine Hydrochloride180 in 1 BOTTLETABLET1801
76282-283-27Cyclobenzaprine Hydrochloride270 in 1 BOTTLETABLET2701
76282-283-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET301
76282-283-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET601
76282-283-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-283-10EA - Each76282-28332816277-5cb4-4870-bdec-757699b56c1412025-05-14
76282-283-18EA - Each76282-2837543a11a-fac4-4ed9-80e7-ddde22f3761a12025-05-14
76282-283-27EA - Each76282-28309093abc-352f-41d5-a8f1-9ece07e5622212025-05-14
76282-283-30EA - Each76282-283aebbf369-2a6a-498b-9f3d-5187522611dc12025-05-14
76282-283-60EA - Each76282-283a0b6ec51-a2ea-4135-8b3c-eec906fa13d312025-05-14
76282-283-90EA - Each76282-2834e14caff-1974-44c4-b140-5143491dd1d312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-283CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET [EXELAN PHARMACEUTICALS, INC.]1Current NDC, 6 package rows20250413_cf81da00-7c6d-4477-bb70-b3c2abea177a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN3bc7e2b4-e1a0-66e3-e063-6294a90a676a1
828348cyclobenzaprine HCl 10 MG Oral TabletPSNcf81da00-7c6d-4477-bb70-b3c2abea177a1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD3bc7e2b4-e1a0-66e3-e063-6294a90a676a1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDcf81da00-7c6d-4477-bb70-b3c2abea177a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-283-10762820283101000 TABLET in 1 BOTTLE (76282-283-10) 1000 tablet2025-04-10NoNoCurrent
76282-283-1876282028318180 TABLET in 1 BOTTLE (76282-283-18) 180 tablet2025-04-10NoNoCurrent
76282-283-2776282028327270 TABLET in 1 BOTTLE (76282-283-27) 270 tablet2025-04-10NoNoCurrent
76282-283-307628202833030 TABLET in 1 BOTTLE (76282-283-30) 30 tablet2025-04-10NoNoCurrent
76282-283-607628202836060 TABLET in 1 BOTTLE (76282-283-60) 60 tablet2025-04-10NoNoCurrent
76282-283-907628202839090 TABLET in 1 BOTTLE (76282-283-90) 90 tablet2025-04-10NoNoCurrent