FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
69097-846
11-digit product format
690970846
Labeler code
69097
Product ID
69097-846_0e5c376d-9599-4825-9226-016d40cf6113
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA090478
Marketing category
ANDA
Marketing start
2016-07-22
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-846-07Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
69097-846-15Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-846CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [CIPLA USA INC.]4Current NDC, Legacy NDC, 2 package rows20210316_575a31fb-04c5-4001-88a7-c33adbacc6a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNae6de8d8-33c2-40bd-9dd3-782c879a9d8f9
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDae6de8d8-33c2-40bd-9dd3-782c879a9d8f9
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4a2b5f25-a333-15f3-e054-00144ff8d46c7
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4a2b5f25-a333-15f3-e054-00144ff8d46c7
828348cyclobenzaprine HCl 10 MG Oral TabletPSN53688de9-2031-4d19-b422-4000285f7f476
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD53688de9-2031-4d19-b422-4000285f7f476
828348cyclobenzaprine HCl 10 MG Oral TabletPSN2ff7cb40-9b43-47fb-a7b4-f9e6e9d65e5b5
828348cyclobenzaprine HCl 10 MG Oral TabletPSN77f5c98e-9196-31d6-e053-2a91aa0a52055
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4fbbc5b6-7aac-34e5-e054-00144ff88e885
828348cyclobenzaprine HCl 10 MG Oral TabletPSN50c28fda-7d64-08ce-e054-00144ff8d46c5
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD2ff7cb40-9b43-47fb-a7b4-f9e6e9d65e5b5
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD77f5c98e-9196-31d6-e053-2a91aa0a52055
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4fbbc5b6-7aac-34e5-e054-00144ff88e885
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD50c28fda-7d64-08ce-e054-00144ff8d46c5
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf4432fc3-ec30-46c6-84aa-19dcf59dfe914
828348cyclobenzaprine HCl 10 MG Oral TabletPSN575a31fb-04c5-4001-88a7-c33adbacc6a84
828348cyclobenzaprine HCl 10 MG Oral TabletPSN269bc278-963d-4830-816a-39bb4bf8c9364
828320cyclobenzaprine HCl 5 MG Oral TabletPSN575a31fb-04c5-4001-88a7-c33adbacc6a84
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD575a31fb-04c5-4001-88a7-c33adbacc6a84
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf4432fc3-ec30-46c6-84aa-19dcf59dfe914
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD269bc278-963d-4830-816a-39bb4bf8c9364
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD575a31fb-04c5-4001-88a7-c33adbacc6a84
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4deda6bd-60ff-1690-e054-00144ff8d46c3
828348cyclobenzaprine HCl 10 MG Oral TabletPSN41709710-5397-3119-e054-00144ff88e883
828348cyclobenzaprine HCl 10 MG Oral TabletPSNc519e446-fa50-487d-a54d-fc3bfdd7d0343
828348cyclobenzaprine HCl 10 MG Oral TabletPSNe04eea45-12ec-4d2b-e053-2a95a90a6b763
828348cyclobenzaprine HCl 10 MG Oral TabletPSNe530fd1e-06fd-0432-e053-2995a90adf5f3
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4deda6bd-60ff-1690-e054-00144ff8d46c3
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD41709710-5397-3119-e054-00144ff88e883
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDc519e446-fa50-487d-a54d-fc3bfdd7d0343
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDe04eea45-12ec-4d2b-e053-2a95a90a6b763
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDe530fd1e-06fd-0432-e053-2995a90adf5f3
828348cyclobenzaprine HCl 10 MG Oral TabletPSN252fb808-90a7-47a5-8557-bf4a8d8c41181
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD252fb808-90a7-47a5-8557-bf4a8d8c41181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-846-0769097084607100 TABLET, FILM COATED in 1 BOTTLE (69097-846-07) 2016-07-220000-00-00NoNoCurrent
69097-846-15690970846151000 TABLET, FILM COATED in 1 BOTTLE (69097-846-15) 2016-07-220000-00-00NoNoCurrent