FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
0093-3420
11-digit product format
000933420
Labeler code
0093
Product ID
0093-3420_43707f11-5cf5-46a1-af67-c12153c11fd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA071611
Marketing category
ANDA
Marketing start
2021-07-20
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P

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
0093-3420-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3420-01EA - Each0093-34202bd66bcf-fc30-46cf-89ea-ca458ca82b3512021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3420CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]4Current NDC, Legacy NDC, 1 package rows20241127_1d9e34cc-eee9-4147-abf8-c810a80e39d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN1d9e34cc-eee9-4147-abf8-c810a80e39d25
828320cyclobenzaprine HCl 5 MG Oral TabletPSN1d9e34cc-eee9-4147-abf8-c810a80e39d25
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN1d9e34cc-eee9-4147-abf8-c810a80e39d25
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD1d9e34cc-eee9-4147-abf8-c810a80e39d25
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD1d9e34cc-eee9-4147-abf8-c810a80e39d25
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD1d9e34cc-eee9-4147-abf8-c810a80e39d25
828320cyclobenzaprine HCl 5 MG Oral TabletPSN0923e84f-5967-4737-ae9d-10a0edeaa9373
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD0923e84f-5967-4737-ae9d-10a0edeaa9373
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf8dec4e2-3151-4a79-b194-a11a57ada0b61
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf8dec4e2-3151-4a79-b194-a11a57ada0b61
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNf8dec4e2-3151-4a79-b194-a11a57ada0b61
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf8dec4e2-3151-4a79-b194-a11a57ada0b61
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf8dec4e2-3151-4a79-b194-a11a57ada0b61
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDf8dec4e2-3151-4a79-b194-a11a57ada0b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-3420-0100093342001100 TABLET, FILM COATED in 1 BOTTLE (0093-3420-01) 2021-07-200000-00-00NoNoCurrent