FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
71205-454
11-digit product format
712050454
Labeler code
71205
Product ID
71205-454_a5a3c82e-1d99-4a5e-82c9-2d1f63f4dd6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091281
Marketing category
ANDA
Marketing start
2019-03-01
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
15 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 HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828358

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
71205-454-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
71205-454-42Cyclobenzaprine Hydrochloride42 in 1 BOTTLECAPSULE, EXTENDED RELEASE422
71205-454-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
71205-454-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-454-30EA - Each71205-454078a43ab-3705-4ed6-ba90-3392c93fc37e12021-04-08
71205-454-42EA - Each71205-454d80b7211-d9b3-401c-8c1a-d5dcee5aba5d12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-454CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 4 package rows20220528_d8112916-28ae-452c-8ec8-a4972e5f549b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNd8112916-28ae-452c-8ec8-a4972e5f549b2
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDd8112916-28ae-452c-8ec8-a4972e5f549b2
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYd8112916-28ae-452c-8ec8-a4972e5f549b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-454-307120504543030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-30) 2020-05-260000-00-00NoNoCurrent
71205-454-427120504544242 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-42) 2020-05-260000-00-00NoNoCurrent
71205-454-607120504546060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-60) 2020-05-260000-00-00NoNoCurrent
71205-454-907120504549090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-90) 2020-05-260000-00-00NoNoCurrent