FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
43063-494
11-digit product format
430630494
Labeler code
43063
Product ID
43063-494_4138b440-6586-92bc-e063-6394a90a3a3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078048
Marketing category
ANDA
Marketing start
2014-07-31
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828320

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
43063-494-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10025
43063-494-10Cyclobenzaprine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1025
43063-494-14Cyclobenzaprine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1425
43063-494-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1525
43063-494-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2025
43063-494-21Cyclobenzaprine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2125
43063-494-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3025
43063-494-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6025
43063-494-82Cyclobenzaprine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50025
43063-494-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9025
43063-494-95Cyclobenzaprine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-494-01EA - Each43063-49490630346-ee90-4287-bcc4-c4e21da38d2012019-01-24
43063-494-10EA - Each43063-494d759abc2-0443-4a1c-88b1-f7fab1a24dbc12014-05-02
43063-494-14EA - Each43063-4943744a16d-0012-4582-bc09-9588c2bf023012015-04-03
43063-494-15EA - Each43063-49434c54175-142d-4f7f-9372-4bbfd1507f7912014-05-02
43063-494-20EA - Each43063-49495e92a0e-7d97-4bcd-a5d4-aa595368f83612019-10-07
43063-494-21EA - Each43063-494c0686b04-f3be-47cb-bd33-6a3c7efe2c2212014-05-02
43063-494-30EA - Each43063-4947f118b1e-0d2a-4982-9cf2-ef04df6c26e812014-09-03
43063-494-60EA - Each43063-4945c02e9a1-6f25-470a-808f-56984bb7b5d512015-02-02
43063-494-82EA - Each43063-4949c1dd30f-47a8-428d-8cd3-4baeeb56f26e12019-01-24
43063-494-95EA - Each43063-494e789fa1f-a78c-450c-a3f5-b2cf2cc1a28f12019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-494CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 11 package rows20240713_e505c31b-4618-4e4f-8da6-92030464004f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNe505c31b-4618-4e4f-8da6-92030464004f25
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDe505c31b-4618-4e4f-8da6-92030464004f25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-494-0143063049401100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-01) 2018-12-050000-00-00NoNoCurrent
43063-494-104306304941010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-10) 2014-07-310000-00-00NoNoCurrent
43063-494-144306304941414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-14) 2014-07-310000-00-00NoNoCurrent
43063-494-154306304941515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-15) 2014-07-310000-00-00NoNoCurrent
43063-494-204306304942020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-20) 2019-09-040000-00-00NoNoCurrent
43063-494-214306304942121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-21) 2014-07-310000-00-00NoNoCurrent
43063-494-304306304943030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-30) 2014-07-310000-00-00NoNoCurrent
43063-494-604306304946060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-60) 2014-07-310000-00-00NoNoCurrent
43063-494-8243063049482500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-82) 2018-12-050000-00-00NoNoCurrent
43063-494-904306304949090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-90) 2014-07-310000-00-00NoNoCurrent
43063-494-95430630494951000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-95) 2018-12-040000-00-00NoNoCurrent