FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
0093-1920
11-digit product format
000931920
Labeler code
0093
Product ID
0093-1920_73a9fa85-9ac0-45b1-8e60-f2bbc4094259
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
NDA021777
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-03-04
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
0093-1920-06Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-1920-06EA - Each0093-192019b13c21-bc26-4e71-8565-6b25f176c27712019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-1920CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 1 package rows20250502_ca74d27a-f7c6-462d-a913-1cfa061bd8f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNca74d27a-f7c6-462d-a913-1cfa061bd8f314
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSNca74d27a-f7c6-462d-a913-1cfa061bd8f314
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDca74d27a-f7c6-462d-a913-1cfa061bd8f314
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCDca74d27a-f7c6-462d-a913-1cfa061bd8f314
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYca74d27a-f7c6-462d-a913-1cfa061bd8f314
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSYca74d27a-f7c6-462d-a913-1cfa061bd8f314
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN2169667d-4f4b-472d-929b-8a0bcbddbe9c5
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD2169667d-4f4b-472d-929b-8a0bcbddbe9c5
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY2169667d-4f4b-472d-929b-8a0bcbddbe9c5
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNe4a3383a-7b30-25b7-e053-2995a90a341b2
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDe4a3383a-7b30-25b7-e053-2995a90a341b2
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYe4a3383a-7b30-25b7-e053-2995a90a341b2
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN259fb05a-4f45-9c8e-e063-6294a90a44841
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNd4457b8c-fff8-4c19-8d5a-a667161e54461
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN96b650d8-4ad5-42af-aa8c-aa0ac25abfb51
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN3a116427-c427-c3bc-e063-6294a90ac5391
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD259fb05a-4f45-9c8e-e063-6294a90a44841
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD3a116427-c427-c3bc-e063-6294a90ac5391
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDd4457b8c-fff8-4c19-8d5a-a667161e54461
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD96b650d8-4ad5-42af-aa8c-aa0ac25abfb51
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY3a116427-c427-c3bc-e063-6294a90ac5391
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY259fb05a-4f45-9c8e-e063-6294a90a44841
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYd4457b8c-fff8-4c19-8d5a-a667161e54461
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY96b650d8-4ad5-42af-aa8c-aa0ac25abfb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-1920-060009319200660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-1920-06) 2019-03-040000-00-00NoNoCurrent