Cyclobenzaprine Hydrochloride

Product NDC
21695-036
11-digit product format
216950036
Labeler code
21695
Product ID
21695-036_caf7ed82-954c-498b-82bc-39fd903ab030
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors
Application
ANDA077563
Marketing category
ANDA
Marketing start
2006-04-19
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-036-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET201
21695-036-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET301
21695-036-72Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET1201
21695-036-78Cyclobenzaprine Hydrochloride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-036-20EA - Each21695-036c52822b5-ce16-479a-a609-9ab88bf1a74512012-07-24
21695-036-30EA - Each21695-0363d3095bd-e1da-4aa5-bbcb-cb646d5a473d12012-07-24
21695-036-72EA - Each21695-036a90cd139-8b07-4ddd-b90e-b8baa356366212012-07-24
21695-036-78EA - Each21695-0366b140acd-8218-4b7f-ba15-da68a93f674812012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-036CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1Legacy NDC, 4 package rows20100331_dd2d3cf8-293c-4c3b-bdce-81f5c6a220ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNdd2d3cf8-293c-4c3b-bdce-81f5c6a220ef1
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDdd2d3cf8-293c-4c3b-bdce-81f5c6a220ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-036-202169500362020 in 1 BOTTLEHistorical
21695-036-302169500363030 in 1 BOTTLEHistorical
21695-036-7221695003672120 in 1 BOTTLEHistorical
21695-036-7821695003678180 in 1 BOTTLEHistorical