FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
76420-010
11-digit product format
764200010
Labeler code
76420
Product ID
76420-010_17d7186f-a791-93d2-e063-6294a90ac7d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA078722
Marketing category
ANDA
Marketing start
2017-09-28
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-010-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
76420-010-05Cyclobenzaprine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5004
76420-010-12Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1204
76420-010-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED154
76420-010-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
76420-010-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
76420-010-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-010-01EA - Each76420-01066eafb92-9919-4470-b286-658683965dc112022-12-07
76420-010-05EA - Each76420-01044524994-a810-4b38-9135-58f0db6548a712022-12-07
76420-010-15EA - Each76420-0100bdcbb18-431a-46ce-aefa-af585661ff6b12022-12-07
76420-010-30EA - Each76420-01058796f92-a2e5-4881-ac6b-32293635a0e612022-12-07
76420-010-60EA - Each76420-010da512150-95b6-4cc8-9988-327b32399fe312022-12-07
76420-010-90EA - Each76420-01047c93814-21fa-4439-bfc1-3df8fe4c0cb912022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-010CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.]4Current NDC, Legacy NDC, 7 package rows20240508_07e3ec53-f1f2-4231-aec6-1772a146ba88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN07e3ec53-f1f2-4231-aec6-1772a146ba884
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD07e3ec53-f1f2-4231-aec6-1772a146ba884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-010-0176420001001100 TABLET, FILM COATED in 1 BOTTLE (76420-010-01) 2022-10-210000-00-00NoNoCurrent
76420-010-0576420001005500 TABLET, FILM COATED in 1 BOTTLE (76420-010-05) 2022-10-210000-00-00NoNoCurrent
76420-010-1276420001012120 TABLET, FILM COATED in 1 BOTTLE (76420-010-12) 2023-03-16NoNoCurrent
76420-010-157642000101515 TABLET, FILM COATED in 1 BOTTLE (76420-010-15) 2022-10-210000-00-00NoNoCurrent
76420-010-307642000103030 TABLET, FILM COATED in 1 BOTTLE (76420-010-30) 2020-01-230000-00-00NoNoCurrent
76420-010-607642000106060 TABLET, FILM COATED in 1 BOTTLE (76420-010-60) 2020-01-230000-00-00NoNoCurrent
76420-010-907642000109090 TABLET, FILM COATED in 1 BOTTLE (76420-010-90) 2022-10-210000-00-00NoNoCurrent