FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
71205-857
11-digit product format
712050857
Labeler code
71205
Product ID
71205-857_ffd82a69-a64c-4399-8f5d-bddc70cdc3cf
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
Rxcui828353, 828358

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
71205-857-00Cyclobenzaprine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001
71205-857-11Cyclobenzaprine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10001
71205-857-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
71205-857-55Cyclobenzaprine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001
71205-857-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
71205-857-72Cyclobenzaprine Hydrochloride120 in 1 BOTTLECAPSULE, EXTENDED RELEASE1201
71205-857-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-857CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 7 package rows20220507_ffd82a69-a64c-4399-8f5d-bddc70cdc3cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNffd82a69-a64c-4399-8f5d-bddc70cdc3cf1
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSNffd82a69-a64c-4399-8f5d-bddc70cdc3cf1
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDffd82a69-a64c-4399-8f5d-bddc70cdc3cf1
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCDffd82a69-a64c-4399-8f5d-bddc70cdc3cf1
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYffd82a69-a64c-4399-8f5d-bddc70cdc3cf1
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSYffd82a69-a64c-4399-8f5d-bddc70cdc3cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-857-0071205085700100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-00) 2022-05-060000-00-00NoNoCurrent
71205-857-11712050857111000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-11) 2022-05-060000-00-00NoNoCurrent
71205-857-307120508573030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-30) 2022-05-060000-00-00NoNoCurrent
71205-857-5571205085755500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-55) 2022-05-060000-00-00NoNoCurrent
71205-857-607120508576060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-60) 2022-05-060000-00-00NoNoCurrent
71205-857-7271205085772120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-72) 2022-05-060000-00-00NoNoCurrent
71205-857-907120508579090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-90) 2022-05-060000-00-00NoNoCurrent