FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
76420-033
11-digit product format
764200033
Labeler code
76420
Product ID
76420-033_f5f82b93-a80e-3ab8-e053-2995a90a68f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA077797
Marketing category
ANDA
Marketing start
2017-03-30
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
76420-033-01Cyclobenzaprine Hydrochloride1 in 1 BOTTLE, PLASTICTABLET, FILM COATED12
76420-033-02Cyclobenzaprine Hydrochloride2 in 1 BOTTLE, PLASTICTABLET, FILM COATED22
76420-033-07Cyclobenzaprine Hydrochloride7 in 1 BOTTLE, PLASTICTABLET, FILM COATED72
76420-033-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
76420-033-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
76420-033-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
76420-033-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-033-01EA - Each76420-03300ef5ecf-1a1d-423c-b3d7-605ceadef2f312022-05-04
76420-033-02EA - Each76420-033d7778138-7f5a-41b8-8346-e8058a5470d612022-05-04
76420-033-07EA - Each76420-03307c8ba40-c667-463c-b122-c61c5855823b12022-05-04
76420-033-20EA - Each76420-033a2a1ae0c-f611-45f3-9f54-6bb35ee2c0ea12022-05-04
76420-033-30EA - Each76420-03327e6a5e5-1ba8-4ac7-988f-fb5a579179d812022-05-04
76420-033-60EA - Each76420-0330427669f-4178-4935-923c-0dc72f812f3712022-05-04
76420-033-90EA - Each76420-033a046fcc8-d0d4-42e8-9ba2-a0fc28de286012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-033CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 7 package rows20230306_68db3c3b-8da1-4852-90b0-3172f842aa02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN68db3c3b-8da1-4852-90b0-3172f842aa022
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD68db3c3b-8da1-4852-90b0-3172f842aa022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-033-01764200033011 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-01) 2020-08-070000-00-00NoNoCurrent
76420-033-02764200033022 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-02) 2020-08-070000-00-00NoNoCurrent
76420-033-07764200033077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-07) 2020-08-070000-00-00NoNoCurrent
76420-033-207642000332020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-20) 2020-08-070000-00-00NoNoCurrent
76420-033-307642000333030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-30) 2020-08-070000-00-00NoNoCurrent
76420-033-607642000336060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-60) 2020-08-070000-00-00NoNoCurrent
76420-033-907642000339090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-90) 2023-03-03NoNoCurrent