FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
76420-271
11-digit product format
764200271
Labeler code
76420
Product ID
76420-271_e7bfa09d-7e18-d2bf-e053-2995a90a9145
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA071611
Marketing category
ANDA
Marketing start
2021-07-20
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
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
76420-271-01Cyclobenzaprine Hydrochloride1 in 1 BOTTLETABLET, FILM COATED11
76420-271-02Cyclobenzaprine Hydrochloride2 in 1 BOTTLETABLET, FILM COATED21
76420-271-07Cyclobenzaprine Hydrochloride7 in 1 BOTTLETABLET, FILM COATED71
76420-271-10Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
76420-271-12Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1201
76420-271-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151
76420-271-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED201
76420-271-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
76420-271-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
76420-271-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-271-01EA - Each76420-271902e8c15-b7a0-4512-87c8-64cfcea0df8912022-10-06
76420-271-02EA - Each76420-2718fd2ca8a-f96b-4063-a1ee-90138317e9e812022-10-06
76420-271-07EA - Each76420-2719b754527-6cad-49df-ad45-459436ae815b12022-10-06
76420-271-10EA - Each76420-27185a1486a-7040-46c4-89d8-f25e43647c2212022-10-06
76420-271-12EA - Each76420-27132b32570-6463-446e-9471-4676e449c1da12022-10-06
76420-271-15EA - Each76420-2715807a101-e1b7-4472-b1f1-78472b68202812022-10-06
76420-271-20EA - Each76420-2713eb962ae-a583-41b4-98af-26c384e4ad2212022-10-06
76420-271-30EA - Each76420-2712f635c6d-6261-42f2-a6e7-16564c1562e112022-10-06
76420-271-60EA - Each76420-2712e71de15-377b-4073-886a-c2e63d1318e912022-10-06
76420-271-90EA - Each76420-2717f011287-3ed9-44ad-a6f8-146549bdb5d212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-271CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 10 package rows20220908_f8dec4e2-3151-4a79-b194-a11a57ada0b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
76420-271-01764200271011 TABLET, FILM COATED in 1 BOTTLE (76420-271-01) 2022-09-030000-00-00NoNoCurrent
76420-271-02764200271022 TABLET, FILM COATED in 1 BOTTLE (76420-271-02) 2022-09-030000-00-00NoNoCurrent
76420-271-07764200271077 TABLET, FILM COATED in 1 BOTTLE (76420-271-07) 2022-09-030000-00-00NoNoCurrent
76420-271-1076420027110100 TABLET, FILM COATED in 1 BOTTLE (76420-271-10) 2022-09-030000-00-00NoNoCurrent
76420-271-1276420027112120 TABLET, FILM COATED in 1 BOTTLE (76420-271-12) 2022-09-030000-00-00NoNoCurrent
76420-271-157642002711515 TABLET, FILM COATED in 1 BOTTLE (76420-271-15) 2022-09-030000-00-00NoNoCurrent
76420-271-207642002712020 TABLET, FILM COATED in 1 BOTTLE (76420-271-20) 2022-09-030000-00-00NoNoCurrent
76420-271-307642002713030 TABLET, FILM COATED in 1 BOTTLE (76420-271-30) 2022-09-030000-00-00NoNoCurrent
76420-271-607642002716060 TABLET, FILM COATED in 1 BOTTLE (76420-271-60) 2022-09-030000-00-00NoNoCurrent
76420-271-907642002719090 TABLET, FILM COATED in 1 BOTTLE (76420-271-90) 2022-09-030000-00-00NoNoCurrent