FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
50090-4727
11-digit product format
500904727
Labeler code
50090
Product ID
50090-4727_0d2d2af6-37df-43fe-8222-c1374734d48a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
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
50090-4727-02023-02-07C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-12023-02-07C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-22023-02-07C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-32023-02-07C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-42023-02-07C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-62023-02-07C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-72023-02-07C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-82023-02-07C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-92023-02-07C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-02023-01-30C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-12023-01-30C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-22023-01-30C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-32023-01-30C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-42023-01-30C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-62023-01-30C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-72023-01-30C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-82023-01-30C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4727-92023-01-30C16284748780-1f386c649-d113-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4727-0CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED1511
50090-4727-1CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED2011
50090-4727-2CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3011
50090-4727-3CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED6011
50090-4727-4CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED10011
50090-4727-6CYCLOBENZAPRINE HYDROCHLORIDE7 in 1 BOTTLETABLET, FILM COATED711
50090-4727-7CYCLOBENZAPRINE HYDROCHLORIDE14 in 1 BOTTLETABLET, FILM COATED1411
50090-4727-8CYCLOBENZAPRINE HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED2111
50090-4727-9CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4727-0EA - Each50090-4727592557a5-7ef3-48b4-b002-0f67d3e5b04c12024-03-12
50090-4727-1EA - Each50090-472767b2a7b1-2ef7-4c95-a221-222e3c48d1e012022-01-06
50090-4727-2EA - Each50090-4727fbfd61e2-6c81-4e5d-a7bc-6c720e28897e12021-08-05
50090-4727-3EA - Each50090-47277d50ee14-4af4-4d88-9bb3-afc015ef21c412024-03-12
50090-4727-4EA - Each50090-47279fcc94e4-4b6e-4e75-996d-daefd89ff80612024-03-12
50090-4727-6EA - Each50090-4727bb682793-3ca2-431a-b014-42b9e5c0fed512021-04-08
50090-4727-7EA - Each50090-4727ec59fc94-5b59-4371-b4a5-639f0e830ece12024-03-12
50090-4727-8EA - Each50090-472748e65334-2c9c-4299-ae17-06ec5ed2023812024-03-12
50090-4727-9EA - Each50090-4727536b1320-962d-4b41-9795-06582e58a96212024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4727CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 9 package rows20240310_eb908b77-741c-473a-b2e9-4f82167c3088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNeb908b77-741c-473a-b2e9-4f82167c308811
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDeb908b77-741c-473a-b2e9-4f82167c308811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4727-05009047270015 TABLET, FILM COATED in 1 BOTTLE (50090-4727-0) 2019-11-180000-00-00NoNoCurrent
50090-4727-15009047270120 TABLET, FILM COATED in 1 BOTTLE (50090-4727-1) 2019-11-180000-00-00NoNoCurrent
50090-4727-25009047270230 TABLET, FILM COATED in 1 BOTTLE (50090-4727-2) 2019-11-180000-00-00NoNoCurrent
50090-4727-35009047270360 TABLET, FILM COATED in 1 BOTTLE (50090-4727-3) 2019-11-180000-00-00NoNoCurrent
50090-4727-450090472704100 TABLET, FILM COATED in 1 BOTTLE (50090-4727-4) 2019-11-180000-00-00NoNoCurrent
50090-4727-6500904727067 TABLET, FILM COATED in 1 BOTTLE (50090-4727-6) 2019-11-180000-00-00NoNoCurrent
50090-4727-75009047270714 TABLET, FILM COATED in 1 BOTTLE (50090-4727-7) 2019-11-180000-00-00NoNoCurrent
50090-4727-85009047270821 TABLET, FILM COATED in 1 BOTTLE (50090-4727-8) 2019-11-180000-00-00NoNoCurrent
50090-4727-95009047270910 TABLET, FILM COATED in 1 BOTTLE (50090-4727-9) 2019-11-180000-00-00NoNoCurrent