FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
50090-5711
11-digit product format
500905711
Labeler code
50090
Product ID
50090-5711_22a3e440-266d-4a3e-a1fe-6df83fea6abd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213324
Marketing category
ANDA
Marketing start
2020-07-06
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5711-02023-02-07C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-12023-02-07C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-22023-02-07C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-32023-02-07C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-42023-02-07C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-62023-02-07C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-72023-02-07C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-82023-02-07C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-92023-02-07C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-02023-01-30C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-12023-01-30C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-22023-01-30C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-32023-01-30C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-42023-01-30C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-62023-01-30C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-72023-01-30C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-82023-01-30C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5711-92023-01-30C16284748780-1f386c649-ab42-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5711-0Cyclobenzaprine hydrochloride15 in 1 BOTTLETABLET, FILM COATED158
50090-5711-1Cyclobenzaprine hydrochloride20 in 1 BOTTLETABLET, FILM COATED208
50090-5711-2Cyclobenzaprine hydrochloride30 in 1 BOTTLETABLET, FILM COATED308
50090-5711-3Cyclobenzaprine hydrochloride60 in 1 BOTTLETABLET, FILM COATED608
50090-5711-4Cyclobenzaprine hydrochloride100 in 1 BOTTLETABLET, FILM COATED1008
50090-5711-6Cyclobenzaprine hydrochloride7 in 1 BOTTLETABLET, FILM COATED78
50090-5711-7Cyclobenzaprine hydrochloride14 in 1 BOTTLETABLET, FILM COATED148
50090-5711-8Cyclobenzaprine hydrochloride21 in 1 BOTTLETABLET, FILM COATED218
50090-5711-9Cyclobenzaprine hydrochloride10 in 1 BOTTLETABLET, FILM COATED108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5711-0EA - Each50090-571115748a60-64d8-4d2f-a137-af5e79625cc312022-08-04
50090-5711-1EA - Each50090-571134e334d8-929e-4055-a8d7-e4c31bac0e3512022-08-04
50090-5711-2EA - Each50090-571143d9cb6b-ffa9-4c60-97b0-d04fb14fe28212022-08-04
50090-5711-3EA - Each50090-571146f3309c-936e-4b80-a012-beb8d283756f12022-08-04
50090-5711-4EA - Each50090-571159a1bdfe-acf3-49a6-9c7b-3df2bb16fcd212022-08-04
50090-5711-6EA - Each50090-571157f5d277-712f-4f7d-b0b6-86dba327b2cd12022-08-04
50090-5711-7EA - Each50090-5711d4a21823-2250-4f07-a470-45652640087412022-08-04
50090-5711-8EA - Each50090-571149eb5d0e-e100-4606-9cff-f73cce54859212022-08-04
50090-5711-9EA - Each50090-57113a51dbd9-fd1c-457b-980e-22bd2710167612022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5711CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 9 package rows20231204_6b06b11c-0546-4f6e-9509-ba612bbcb9fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN6b06b11c-0546-4f6e-9509-ba612bbcb9fd8
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD6b06b11c-0546-4f6e-9509-ba612bbcb9fd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5711-05009057110015 TABLET, FILM COATED in 1 BOTTLE (50090-5711-0) 2021-09-240000-00-00NoNoCurrent
50090-5711-15009057110120 TABLET, FILM COATED in 1 BOTTLE (50090-5711-1) 2021-09-240000-00-00NoNoCurrent
50090-5711-25009057110230 TABLET, FILM COATED in 1 BOTTLE (50090-5711-2) 2021-09-240000-00-00NoNoCurrent
50090-5711-35009057110360 TABLET, FILM COATED in 1 BOTTLE (50090-5711-3) 2021-09-240000-00-00NoNoCurrent
50090-5711-450090571104100 TABLET, FILM COATED in 1 BOTTLE (50090-5711-4) 2021-09-240000-00-00NoNoCurrent
50090-5711-6500905711067 TABLET, FILM COATED in 1 BOTTLE (50090-5711-6) 2021-09-240000-00-00NoNoCurrent
50090-5711-75009057110714 TABLET, FILM COATED in 1 BOTTLE (50090-5711-7) 2021-09-240000-00-00NoNoCurrent
50090-5711-85009057110821 TABLET, FILM COATED in 1 BOTTLE (50090-5711-8) 2021-09-240000-00-00NoNoCurrent
50090-5711-95009057110910 TABLET, FILM COATED in 1 BOTTLE (50090-5711-9) 2021-09-240000-00-00NoNoCurrent