FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
72888-014
11-digit product format
728880014
Labeler code
72888
Product ID
72888-014_484568be-57f8-943e-e063-6394a90a589b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299, 828320, 828348

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
72888-014-00CYCLOBENZAPRINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10006
72888-014-01CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1006
72888-014-05CYCLOBENZAPRINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-014-00EA - Each72888-014cbdf5ff7-1121-463b-9580-8c63b9182f4b12021-04-08
72888-014-01EA - Each72888-014837677ef-a87c-46d4-8e7f-ca4fe7bedd6812021-06-02
72888-014-05EA - Each72888-014cf5acc31-b33b-4575-8e61-875fe40ad13312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-014CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ADVAGEN PHARMA LIMITED]5Current NDC, Legacy NDC, 3 package rows20241222_b2169957-9083-412c-a175-3071860c2b43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN8bef97d4-1b92-4316-8733-7751d627230f14
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD8bef97d4-1b92-4316-8733-7751d627230f14
828348cyclobenzaprine HCl 10 MG Oral TabletPSNfe81c68d-a579-4fe9-e053-6294a90a7bc08
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDfe81c68d-a579-4fe9-e053-6294a90a7bc08
828348cyclobenzaprine HCl 10 MG Oral TabletPSNb2169957-9083-412c-a175-3071860c2b436
828320cyclobenzaprine HCl 5 MG Oral TabletPSNb2169957-9083-412c-a175-3071860c2b436
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNb2169957-9083-412c-a175-3071860c2b436
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDb2169957-9083-412c-a175-3071860c2b436
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDb2169957-9083-412c-a175-3071860c2b436
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDb2169957-9083-412c-a175-3071860c2b436
828348cyclobenzaprine HCl 10 MG Oral TabletPSN15aad4af-5c05-be36-e063-6294a90a9bb34
828348cyclobenzaprine HCl 10 MG Oral TabletPSNe343fd12-1ca2-418a-b690-f3e8f567596d4
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDe343fd12-1ca2-418a-b690-f3e8f567596d4
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD15aad4af-5c05-be36-e063-6294a90a9bb34
828348cyclobenzaprine HCl 10 MG Oral TabletPSN24653b10-bdf0-47c5-a1f4-dc25f3b860323
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf32bceda-1d24-322d-e053-2995a90aae1b3
828348cyclobenzaprine HCl 10 MG Oral TabletPSN0ab1b6f8-5d73-f97a-e063-6294a90a9fbf3
828348cyclobenzaprine HCl 10 MG Oral TabletPSN00dbe051-a392-e2c6-e063-6394a90ab7f33
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD00dbe051-a392-e2c6-e063-6394a90ab7f33
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf32bceda-1d24-322d-e053-2995a90aae1b3
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD0ab1b6f8-5d73-f97a-e063-6294a90a9fbf3
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD24653b10-bdf0-47c5-a1f4-dc25f3b860323
828348cyclobenzaprine HCl 10 MG Oral TabletPSN0f8ba2c0-38e7-a536-e063-6294a90ace8d2
828348cyclobenzaprine HCl 10 MG Oral TabletPSNdfe7288c-a477-4f32-a9ab-00cc981a1a572
828348cyclobenzaprine HCl 10 MG Oral TabletPSN96207b29-033b-46a3-961f-e5125288d50f2
828348cyclobenzaprine HCl 10 MG Oral TabletPSNdc3cc6b6-c692-4986-8ff7-3a6cd8c85cb22
828348cyclobenzaprine HCl 10 MG Oral TabletPSN418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828320cyclobenzaprine HCl 5 MG Oral TabletPSN418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDdc3cc6b6-c692-4986-8ff7-3a6cd8c85cb22
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDdfe7288c-a477-4f32-a9ab-00cc981a1a572
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD96207b29-033b-46a3-961f-e5125288d50f2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD0f8ba2c0-38e7-a536-e063-6294a90ace8d2
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828348cyclobenzaprine HCl 10 MG Oral TabletPSN3a90171b-aef3-0691-e063-6294a90a65601
828348cyclobenzaprine HCl 10 MG Oral TabletPSN37c8c0d6-98c0-c1a5-e063-6394a90a79311
828348cyclobenzaprine HCl 10 MG Oral TabletPSN30ca08c7-4ee3-2f37-e063-6294a90ae31a1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD3a90171b-aef3-0691-e063-6294a90a65601
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD37c8c0d6-98c0-c1a5-e063-6394a90a79311
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD30ca08c7-4ee3-2f37-e063-6294a90ae31a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-014-00728880014001000 TABLET, FILM COATED in 1 BOTTLE (72888-014-00) 2017-05-310000-00-00NoNoCurrent
72888-014-0172888001401100 TABLET, FILM COATED in 1 BOTTLE (72888-014-01) 2017-05-310000-00-00NoNoCurrent
72888-014-0572888001405500 TABLET, FILM COATED in 1 BOTTLE (72888-014-05) 2017-05-310000-00-00NoNoCurrent