FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
42291-154
11-digit product format
422910154
Labeler code
42291
Product ID
42291-154_3ab20dcb-627a-53c4-e063-6394a90a20cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA077563
Marketing category
ANDA
Marketing start
2020-04-03
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
42291-154-10Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10003
42291-154-12Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1203
42291-154-18Cyclobenzaprine Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1803
42291-154-27Cyclobenzaprine Hydrochloride270 in 1 BOTTLETABLET, FILM COATED2703
42291-154-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
42291-154-45Cyclobenzaprine Hydrochloride45 in 1 BOTTLETABLET, FILM COATED453
42291-154-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
42291-154-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-154-10EA - Each42291-154b7cefd36-bf1e-4f9a-ae34-4442e46d128212020-05-08
42291-154-12EA - Each42291-154efce7257-c9a7-4a54-8afa-5a1036b5954212020-05-08
42291-154-18EA - Each42291-1546a7d2c2e-717c-46e0-a8b1-d2c4a039163012020-05-08
42291-154-27EA - Each42291-1545702c69f-f1ab-45ed-9785-09e78ea2251512020-05-08
42291-154-30EA - Each42291-154edf9047f-adde-4c03-bc95-d963a9a19c9a12020-05-08
42291-154-45EA - Each42291-15430cef5c5-1edb-4cfa-9a37-53448d5f29f812020-05-08
42291-154-60EA - Each42291-154f593e72b-2d73-45b3-a1ab-677f4c2cc4e312020-05-08
42291-154-90EA - Each42291-154b31b20bf-298e-4c14-8bcb-dd5ba515ccb512020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-154CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE]2Current NDC, Legacy NDC, 8 package rows20220114_a264ab9f-cc12-325f-e053-2a95a90a53d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNa264ab9f-cc12-325f-e053-2a95a90a53d93
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDa264ab9f-cc12-325f-e053-2a95a90a53d93
828348cyclobenzaprine HCl 10 MG Oral TabletPSN34f4e63a-1259-0226-e063-6294a90a9fc42
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD34f4e63a-1259-0226-e063-6294a90a9fc42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-154-10422910154101000 TABLET, FILM COATED in 1 BOTTLE (42291-154-10) 2020-04-030000-00-00NoNoCurrent
42291-154-1242291015412120 TABLET, FILM COATED in 1 BOTTLE (42291-154-12) 2020-04-030000-00-00NoNoCurrent
42291-154-1842291015418180 TABLET, FILM COATED in 1 BOTTLE (42291-154-18) 2020-04-030000-00-00NoNoCurrent
42291-154-2742291015427270 TABLET, FILM COATED in 1 BOTTLE (42291-154-27) 2020-04-030000-00-00NoNoCurrent
42291-154-304229101543030 TABLET, FILM COATED in 1 BOTTLE (42291-154-30) 2020-04-030000-00-00NoNoCurrent
42291-154-454229101544545 TABLET, FILM COATED in 1 BOTTLE (42291-154-45) 2020-04-030000-00-00NoNoCurrent
42291-154-604229101546060 TABLET, FILM COATED in 1 BOTTLE (42291-154-60) 2020-04-030000-00-00NoNoCurrent
42291-154-904229101549090 TABLET, FILM COATED in 1 BOTTLE (42291-154-90) 2020-04-030000-00-00NoNoCurrent