FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
0115-1437
11-digit product format
001151437
Labeler code
0115
Product ID
0115-1437_8e7da23f-dda8-4834-91ae-0691668d1374
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
NDA021777
Marketing category
NDA AUTHORIZED GENERIC
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
0115-1437-13Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1437-13EA - Each0115-14371973cea3-9aea-4d63-9846-fdefb2fef65c12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1437CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]13Current NDC, Legacy NDC, 1 package rows20250529_dd546a0e-e5be-4232-8ad8-fcd7d5f9a903.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNdd546a0e-e5be-4232-8ad8-fcd7d5f9a90313
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSNdd546a0e-e5be-4232-8ad8-fcd7d5f9a90313
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDdd546a0e-e5be-4232-8ad8-fcd7d5f9a90313
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCDdd546a0e-e5be-4232-8ad8-fcd7d5f9a90313
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYdd546a0e-e5be-4232-8ad8-fcd7d5f9a90313
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSYdd546a0e-e5be-4232-8ad8-fcd7d5f9a90313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1437-130011514371360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1437-13) 2019-03-010000-00-00NoNoCurrent