FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
76420-895
11-digit product format
764200895
Labeler code
76420
Product ID
76420-895_2b1fe790-9c6e-85ed-e063-6294a90a6471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-895-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001
76420-895-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
76420-895-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
76420-895-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-895-01EA - Each76420-895c1fe552f-d015-4567-ad8d-7c16b60ef28212025-05-14
76420-895-30EA - Each76420-895aa5836f8-1442-4de1-bdd8-48703627d5cb12025-05-14
76420-895-60EA - Each76420-8957e37fdb5-698c-410c-bf56-5e835f7edeed12025-05-14
76420-895-90EA - Each76420-8953ee060cd-9b9b-45e8-b1c8-494ee069a80a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-895CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ASCLEMED USA, INC.]1Current NDC, 4 package rows20250109_3dd2bde1-f06d-493a-91c7-22b28a5e1699.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN3dd2bde1-f06d-493a-91c7-22b28a5e16991
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSN3dd2bde1-f06d-493a-91c7-22b28a5e16991
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD3dd2bde1-f06d-493a-91c7-22b28a5e16991
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCD3dd2bde1-f06d-493a-91c7-22b28a5e16991
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY3dd2bde1-f06d-493a-91c7-22b28a5e16991
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY3dd2bde1-f06d-493a-91c7-22b28a5e16991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-895-0176420089501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-01) 2025-01-07NoNoHistorical
76420-895-307642008953030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-30) 2025-01-07NoNoHistorical
76420-895-607642008956060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-60) 2025-01-07NoNoHistorical
76420-895-907642008959090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-90) 2025-01-07NoNoHistorical