FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
53149-4852
11-digit product format
531494852
Labeler code
53149
Product ID
53149-4852_f5438822-9dae-42b8-b9c7-c11933ba1824
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
All Pharma, LLC
Application
ANDA078722
Marketing category
ANDA
Marketing start
2017-08-01
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53149-4852-12020-01-31C16284748780-19d75b9d0-ba70-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
53149-4852-32020-01-31C16284748780-19d75b9d0-ba70-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
53149-4852-62020-01-31C16284748780-19d75b9d0-ba70-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
53149-4852-92020-01-31C16284748780-19d75b9d0-ba70-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-4852-1Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1202
53149-4852-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
53149-4852-6Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
53149-4852-9Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53149-4852-1EA - Each53149-48526d805f80-7cf1-49bf-9edc-28b8aa91a08f12018-10-11
53149-4852-3EA - Each53149-48523280939d-42e4-4711-8262-6a9b1cd56f8912018-10-11
53149-4852-6EA - Each53149-4852176332fa-3b96-40bc-a7bd-fccd36ecf10912018-10-11
53149-4852-9EA - Each53149-48521425e5c4-c107-41b9-a3e2-97a3c77cc6b012018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-4852CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ALL PHARMA, LLC]2Legacy NDC, 4 package rows20180814_a4f851e5-ef99-4a09-b120-5f9c874f7143.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNa4f851e5-ef99-4a09-b120-5f9c874f71432
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDa4f851e5-ef99-4a09-b120-5f9c874f71432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53149-4852-153149485201120 in 1 BOTTLEHistorical
53149-4852-35314948520330 in 1 BOTTLEHistorical
53149-4852-65314948520660 in 1 BOTTLEHistorical
53149-4852-95314948520990 in 1 BOTTLEHistorical