FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
43547-400
11-digit product format
435470400
Labeler code
43547
Product ID
43547-400_0318717e-68e2-48bc-aa86-d34101d2bd25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
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
Rxcui828320, 828348

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43547-400-012020-03-05C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-092020-03-05C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-102020-03-05C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-112020-03-05C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-182020-03-05C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-272020-03-05C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-502020-03-05C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-512020-03-05C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-012020-01-31C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-092020-01-31C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-102020-01-31C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-112020-01-31C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-182020-01-31C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-272020-01-31C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-502020-01-31C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-512020-01-31C16284748780-19d75b9d1-058b-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-400-01Cyclobenzaprine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED103
43547-400-09Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
43547-400-10Cyclobenzaprine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003
43547-400-11Cyclobenzaprine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10003
43547-400-18Cyclobenzaprine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1803
43547-400-27Cyclobenzaprine Hydrochloride270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2703
43547-400-50Cyclobenzaprine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5003
43547-400-51Cyclobenzaprine Hydrochloride5000 in 1 BOTTLE, PLASTICTABLET, FILM COATED50003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-400-10EA - Each43547-400f4597b53-75d1-4759-b61c-b969e8bf9bf612017-05-03
43547-400-11EA - Each43547-4001dd1fc73-8a41-46b0-be2e-88f3b3ef55a012017-05-03
43547-400-50EA - Each43547-40049a9bfdc-6af0-43b4-b4ce-1a69b66e0ef812017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-400CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]3Current NDC, Legacy NDC, 8 package rows20250402_f558863b-ea3f-4e4b-85e9-edb2573e7151.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4c51f56b-33c3-4611-bba8-876d9dde7aff103
828348cyclobenzaprine HCl 10 MG Oral TabletPSNaa29e260-fb77-415a-a505-3230d30c8945103
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4c51f56b-33c3-4611-bba8-876d9dde7aff103
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDaa29e260-fb77-415a-a505-3230d30c8945103
828348cyclobenzaprine HCl 10 MG Oral TabletPSNaa429426-571d-4b5b-a599-6d71bed9f096102
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDaa429426-571d-4b5b-a599-6d71bed9f096102
828348cyclobenzaprine HCl 10 MG Oral TabletPSNc86303a0-7c8b-415e-acac-1070b7d0d445101
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDc86303a0-7c8b-415e-acac-1070b7d0d445101
828348cyclobenzaprine HCl 10 MG Oral TabletPSN90c7a982-6442-4241-a60b-b5dfab2abb71100
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD90c7a982-6442-4241-a60b-b5dfab2abb71100
828348cyclobenzaprine HCl 10 MG Oral TabletPSN7829a96a-3668-4d88-90e9-0ecbedb2bd7e17
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD7829a96a-3668-4d88-90e9-0ecbedb2bd7e17
828348cyclobenzaprine HCl 10 MG Oral TabletPSN3aaa4808-7f2d-410c-9b6c-193549ec084514
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD3aaa4808-7f2d-410c-9b6c-193549ec084514
828348cyclobenzaprine HCl 10 MG Oral TabletPSN52a30c84-3234-0aa5-e054-00144ff88e887
828348cyclobenzaprine HCl 10 MG Oral TabletPSN9161cb5e-63e5-41d7-9bde-66c7b7b7a2f37
828348cyclobenzaprine HCl 10 MG Oral TabletPSNafcad582-ab59-4f70-e053-2a95a90a04e47
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD52a30c84-3234-0aa5-e054-00144ff88e887
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD9161cb5e-63e5-41d7-9bde-66c7b7b7a2f37
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDafcad582-ab59-4f70-e053-2a95a90a04e47
828348cyclobenzaprine HCl 10 MG Oral TabletPSN643c0b19-01c9-e477-e053-2a91aa0a529c6
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD643c0b19-01c9-e477-e053-2a91aa0a529c6
828348cyclobenzaprine HCl 10 MG Oral TabletPSN43cc254b-6633-63dd-e054-00144ff88e883
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf558863b-ea3f-4e4b-85e9-edb2573e71513
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf558863b-ea3f-4e4b-85e9-edb2573e71513
828320cyclobenzaprine HCl 5 MG Oral TabletPSN43cc254b-6633-63dd-e054-00144ff88e883
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD43cc254b-6633-63dd-e054-00144ff88e883
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf558863b-ea3f-4e4b-85e9-edb2573e71513
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD43cc254b-6633-63dd-e054-00144ff88e883
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf558863b-ea3f-4e4b-85e9-edb2573e71513
828348cyclobenzaprine HCl 10 MG Oral TabletPSN571fbb2b-24e0-4de3-8cfa-c267fc397b6c2
828348cyclobenzaprine HCl 10 MG Oral TabletPSN68db3c3b-8da1-4852-90b0-3172f842aa022
828348cyclobenzaprine HCl 10 MG Oral TabletPSN35fb2777-e4c5-41cb-8695-3ccabec4e0a42
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD68db3c3b-8da1-4852-90b0-3172f842aa022
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD571fbb2b-24e0-4de3-8cfa-c267fc397b6c2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD35fb2777-e4c5-41cb-8695-3ccabec4e0a42
828348cyclobenzaprine HCl 10 MG Oral TabletPSNbbb67b5b-d96b-9eca-e053-2a95a90ab5af1
828348cyclobenzaprine HCl 10 MG Oral TabletPSN2f976e5f-b9c1-48e1-94f4-e85a8fd03fb91
828348cyclobenzaprine HCl 10 MG Oral TabletPSNbe5201bc-e1f1-41af-be46-4a8fbb223b861
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDbe5201bc-e1f1-41af-be46-4a8fbb223b861
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDbbb67b5b-d96b-9eca-e053-2a95a90ab5af1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD2f976e5f-b9c1-48e1-94f4-e85a8fd03fb91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-400-014354704000110 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-01) 2017-03-300000-00-00NoNoCurrent
43547-400-094354704000990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-09) 2017-03-300000-00-00NoNoCurrent
43547-400-1043547040010100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-10) 2017-03-300000-00-00NoNoCurrent
43547-400-11435470400111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-11) 2017-03-300000-00-00NoNoCurrent
43547-400-1843547040018180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-18) 2017-03-300000-00-00NoNoCurrent
43547-400-2743547040027270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-27) 2017-03-300000-00-00NoNoCurrent
43547-400-5043547040050500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-50) 2017-03-300000-00-00NoNoCurrent
43547-400-51435470400515000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-51) 2017-03-300000-00-00NoNoCurrent