FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
72789-036
11-digit product format
727890036
Labeler code
72789
Product ID
72789-036_34032d5b-b9ee-6ece-e063-6294a90a36ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
72789-036-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10014
72789-036-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1514
72789-036-21Cyclobenzaprine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2114
72789-036-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
72789-036-45Cyclobenzaprine Hydrochloride45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4514
72789-036-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6014
72789-036-82Cyclobenzaprine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50014
72789-036-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014
72789-036-93Cyclobenzaprine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18014
72789-036-94Cyclobenzaprine Hydrochloride270 in 1 BOTTLE, PLASTICTABLET, FILM COATED27014
72789-036-95Cyclobenzaprine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100014
72789-036-98Cyclobenzaprine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, FILM COATED12014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-036-01EA - Each72789-036e022df03-2a1b-4fa7-a225-ceb164458e3912020-01-03
72789-036-15EA - Each72789-0364fca7287-d610-48e6-ad64-74c2c052006a12020-02-13
72789-036-21EA - Each72789-0366c7ee897-3670-4abe-9080-d38930ca3f9b12020-02-13
72789-036-30EA - Each72789-0369758be1c-3005-4f97-905c-7800604ce39c12020-03-10
72789-036-45EA - Each72789-036106e889a-d19f-4024-b92b-3f8589c3104e12020-04-20
72789-036-60EA - Each72789-036cdbfc813-1192-43b1-9c81-bc47079e0bca12020-04-20
72789-036-82EA - Each72789-0361dbb3c10-dae1-410d-9cd7-3b7f3ef6a16812020-01-03
72789-036-90EA - Each72789-0369c914240-dc9c-4530-b41a-5bf90adff34912020-04-20
72789-036-93EA - Each72789-03659ca56ea-ad1c-4845-b541-b7953ed743b812020-04-20
72789-036-94EA - Each72789-03641270704-36f7-479d-ac39-8fb3a2507cbf12020-04-20
72789-036-95EA - Each72789-0367052310b-48ee-4b65-8768-d4fa3ad56b3712020-01-03
72789-036-98EA - Each72789-036caf3d964-6c00-4eb1-9ea6-1a936e1b0e5c12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-036CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 12 package rows20250502_3aaa4808-7f2d-410c-9b6c-193549ec0845.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN3aaa4808-7f2d-410c-9b6c-193549ec084514
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD3aaa4808-7f2d-410c-9b6c-193549ec084514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-036-0172789003601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-01) 2019-12-130000-00-00NoNoCurrent
72789-036-157278900361515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-15) 2017-03-300000-00-00NoNoCurrent
72789-036-217278900362121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-21) 2017-03-300000-00-00NoNoCurrent
72789-036-307278900363030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-30) 2020-02-250000-00-00NoNoCurrent
72789-036-457278900364545 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-45) 2020-02-250000-00-00NoNoCurrent
72789-036-607278900366060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-60) 2020-02-250000-00-00NoNoCurrent
72789-036-8272789003682500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-82) 2019-12-130000-00-00NoNoCurrent
72789-036-907278900369090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-90) 2020-02-250000-00-00NoNoCurrent
72789-036-9372789003693180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-93) 2020-02-250000-00-00NoNoCurrent
72789-036-9472789003694270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-94) 2020-02-250000-00-00NoNoCurrent
72789-036-95727890036951000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-95) 2019-12-130000-00-00NoNoCurrent
72789-036-9872789003698120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-98) 2020-02-250000-00-00NoNoCurrent