FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
71205-858
11-digit product format
712050858
Labeler code
71205
Product ID
71205-858_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
30 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 HYDROCHLORIDE30 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
71205-858-00Cyclobenzaprine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001
71205-858-11Cyclobenzaprine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10001
71205-858-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
71205-858-55Cyclobenzaprine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001
71205-858-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
71205-858-72Cyclobenzaprine Hydrochloride120 in 1 BOTTLECAPSULE, EXTENDED RELEASE1201
71205-858-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-858-00EA - Each71205-858ba212619-ddd0-42b3-9424-b79d25fd3c7e12022-06-06
71205-858-11EA - Each71205-858c734f7bf-8e83-4774-9a53-b71cee26383612022-06-06
71205-858-30EA - Each71205-8587c63968a-3dfb-460d-b52a-e7d926183c6412022-06-06
71205-858-55EA - Each71205-858bd489bdd-95e5-4873-8c0b-84d5a8f508b712022-06-06
71205-858-60EA - Each71205-8585c831891-3698-4691-a14f-06428b67b74912022-06-06
71205-858-72EA - Each71205-858cea18293-b73b-4048-9c45-7688588923c412022-06-06
71205-858-90EA - Each71205-858cb2cb83d-65b0-42e3-a5e6-da9ac956306412022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-858CYCLOBENZAPRINE 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
71205-858-0071205085800100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-858-00) 2022-05-060000-00-00NoNoCurrent
71205-858-11712050858111000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-858-11) 2022-05-060000-00-00NoNoCurrent
71205-858-307120508583030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-858-30) 2022-05-060000-00-00NoNoCurrent
71205-858-5571205085855500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-858-55) 2022-05-060000-00-00NoNoCurrent
71205-858-607120508586060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-858-60) 2022-05-060000-00-00NoNoCurrent
71205-858-7271205085872120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-858-72) 2022-05-060000-00-00NoNoCurrent
71205-858-907120508589090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-858-90) 2022-05-060000-00-00NoNoCurrent