FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
71610-016
11-digit product format
716100016
Labeler code
71610
Product ID
71610-016_a35560e7-0593-4c49-87b1-8971ff6df820
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078048
Marketing category
ANDA
Marketing start
2014-07-31
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828348

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
71610-016-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
71610-016-45Cyclobenzaprine Hydrochloride45 in 1 BOTTLETABLET, FILM COATED453
71610-016-53Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
71610-016-70Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1203
71610-016-92Cyclobenzaprine Hydrochloride270 in 1 BOTTLETABLET, FILM COATED2703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-016-30EA - Each71610-016a0529279-f425-4cd5-9212-4c0c51255fab12020-07-13
71610-016-45EA - Each71610-016f63abd8b-927d-4564-8bbf-1fc02350f02512018-03-08
71610-016-53EA - Each71610-01602dba011-7fd8-4ea9-b2be-43813760d5f812020-07-13
71610-016-70EA - Each71610-0168a3a9fbc-1fc5-43f1-8033-759dc2e0c6f212020-07-13
71610-016-92EA - Each71610-016d8ea6052-a1ea-4634-933b-a77766c5bf2f12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-016CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 5 package rows20200607_bb23383c-087a-4fb1-8917-edecd1ec4527.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNbb23383c-087a-4fb1-8917-edecd1ec45273
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDbb23383c-087a-4fb1-8917-edecd1ec45273

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-016-307161000163030 TABLET, FILM COATED in 1 BOTTLE (71610-016-30) 2020-04-080000-00-00NoNoCurrent
71610-016-457161000164545 TABLET, FILM COATED in 1 BOTTLE (71610-016-45) 2017-12-070000-00-00NoNoCurrent
71610-016-537161000165360 TABLET, FILM COATED in 1 BOTTLE (71610-016-53) 2020-05-050000-00-00NoNoCurrent
71610-016-7071610001670120 TABLET, FILM COATED in 1 BOTTLE (71610-016-70) 2020-05-050000-00-00NoNoCurrent
71610-016-9271610001692270 TABLET, FILM COATED in 1 BOTTLE (71610-016-92) 2017-12-270000-00-00NoNoCurrent