FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
72789-046
11-digit product format
727890046
Labeler code
72789
Product ID
72789-046_3403a5e2-c822-d823-e063-6394a90a7142
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
72789-046-03Cyclobenzaprine Hydrochloride3 in 1 BOTTLE, PLASTICTABLET, FILM COATED317
72789-046-04Cyclobenzaprine Hydrochloride4 in 1 BOTTLE, PLASTICTABLET, FILM COATED417
72789-046-06Cyclobenzaprine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED617
72789-046-10Cyclobenzaprine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1017
72789-046-12Cyclobenzaprine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1217
72789-046-14Cyclobenzaprine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1417
72789-046-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2017
72789-046-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3017
72789-046-40Cyclobenzaprine Hydrochloride40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4017
72789-046-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-046-03EA - Each72789-046b2e59164-480d-4286-b347-78ae9282043112020-02-13
72789-046-04EA - Each72789-0464c5febaa-d81b-47d1-9abc-e58c272fa4cd12020-04-20
72789-046-06EA - Each72789-046e8220df3-2a8c-4d0e-8858-25b6317271c112020-09-14
72789-046-10EA - Each72789-046faf78c6a-d737-446f-878c-1d4579e68ebf12020-02-13
72789-046-12EA - Each72789-04634a85cd9-15b7-454d-ae5d-cbb83aba279112020-08-06
72789-046-14EA - Each72789-046b8fe7e5d-f785-42f8-b569-e5732092387812020-04-20
72789-046-20EA - Each72789-046697aa9be-6a49-4c4b-8c4b-6987cbb32f8812020-02-13
72789-046-30EA - Each72789-04684a6e376-7468-4082-810c-5c4756b2baa412020-02-13
72789-046-40EA - Each72789-046fb6fd39c-c747-4c74-bd4a-476bf990b6e612020-08-06
72789-046-60EA - Each72789-0461938dd5e-d47f-4b91-bd36-bfc0fcd512dc12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-046CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 10 package rows20250502_7829a96a-3668-4d88-90e9-0ecbedb2bd7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN7829a96a-3668-4d88-90e9-0ecbedb2bd7e17
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD7829a96a-3668-4d88-90e9-0ecbedb2bd7e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-046-03727890046033 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-03) 2020-01-070000-00-00NoNoCurrent
72789-046-04727890046044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-04) 2020-01-060000-00-00NoNoCurrent
72789-046-06727890046066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-06) 2020-07-170000-00-00NoNoCurrent
72789-046-107278900461010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-10) 2020-01-080000-00-00NoNoCurrent
72789-046-127278900461212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-12) 2020-06-150000-00-00NoNoCurrent
72789-046-147278900461414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-14) 2020-01-270000-00-00NoNoCurrent
72789-046-207278900462020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-20) 2020-01-060000-00-00NoNoCurrent
72789-046-307278900463030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-30) 2020-01-060000-00-00NoNoCurrent
72789-046-407278900464040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-40) 2020-06-010000-00-00NoNoCurrent
72789-046-607278900466060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-60) 2020-01-060000-00-00NoNoCurrent