FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
24979-035
11-digit product format
249790035
Labeler code
24979
Product ID
24979-035_6d0e5e16-1e01-4ce6-9200-bdb5a651e923
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24979-035-042023-02-01C16284748780-1f386c649-a4d9-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. CYCLOBENZAPRINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1977
24979-035-042023-01-30C16284748780-1f386c649-a4d9-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. CYCLOBENZAPRINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1977

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24979-035-04Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-035CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20241018_14f64ceb-ea5c-4d7c-a0c1-3f6a64847290.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN14f64ceb-ea5c-4d7c-a0c1-3f6a648472908
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSN14f64ceb-ea5c-4d7c-a0c1-3f6a648472908
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD14f64ceb-ea5c-4d7c-a0c1-3f6a648472908
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCD14f64ceb-ea5c-4d7c-a0c1-3f6a648472908
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY14f64ceb-ea5c-4d7c-a0c1-3f6a648472908
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY14f64ceb-ea5c-4d7c-a0c1-3f6a648472908
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN550d3e5a-c95f-4094-a500-1a02ea35a18d5
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD550d3e5a-c95f-4094-a500-1a02ea35a18d5
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY550d3e5a-c95f-4094-a500-1a02ea35a18d5
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNd8112916-28ae-452c-8ec8-a4972e5f549b2
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNba659e1a-0091-45f6-b418-f4f36c9a2c792
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNa512d34c-8164-0c04-e053-2995a90a19422
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDd8112916-28ae-452c-8ec8-a4972e5f549b2
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDba659e1a-0091-45f6-b418-f4f36c9a2c792
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDa512d34c-8164-0c04-e053-2995a90a19422
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYd8112916-28ae-452c-8ec8-a4972e5f549b2
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYba659e1a-0091-45f6-b418-f4f36c9a2c792
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYa512d34c-8164-0c04-e053-2995a90a19422
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN3dd2bde1-f06d-493a-91c7-22b28a5e16991
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNffd82a69-a64c-4399-8f5d-bddc70cdc3cf1
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNbfdd9460-5dfa-4588-8f4f-9d227c1717d51
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN2998c9e6-2f60-ef35-e063-6394a90a7bc71
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN48c33e51-db07-af68-e063-6294a90a897e1
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSNffd82a69-a64c-4399-8f5d-bddc70cdc3cf1
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSN3dd2bde1-f06d-493a-91c7-22b28a5e16991
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD2998c9e6-2f60-ef35-e063-6394a90a7bc71
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDffd82a69-a64c-4399-8f5d-bddc70cdc3cf1
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD3dd2bde1-f06d-493a-91c7-22b28a5e16991
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDbfdd9460-5dfa-4588-8f4f-9d227c1717d51
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD48c33e51-db07-af68-e063-6294a90a897e1
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCD3dd2bde1-f06d-493a-91c7-22b28a5e16991
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCDffd82a69-a64c-4399-8f5d-bddc70cdc3cf1
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYbfdd9460-5dfa-4588-8f4f-9d227c1717d51
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY3dd2bde1-f06d-493a-91c7-22b28a5e16991
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY48c33e51-db07-af68-e063-6294a90a897e1
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY2998c9e6-2f60-ef35-e063-6394a90a7bc71
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYffd82a69-a64c-4399-8f5d-bddc70cdc3cf1
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY3dd2bde1-f06d-493a-91c7-22b28a5e16991
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
24979-035-042497900350460 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-035-04) 2019-03-010000-00-00NoNoCurrent