FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
50090-5756
11-digit product format
500905756
Labeler code
50090
Product ID
50090-5756_26f5cef8-35eb-4cc3-b7b4-7f48b1e3526c
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5756-02023-02-06C16284748780-1f386c64a-05bb-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5756-12023-02-06C16284748780-1f386c64a-05bb-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5756-22023-02-06C16284748780-1f386c64a-05bb-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5756-32023-02-06C16284748780-1f386c64a-05bb-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5756-02023-01-30C16284748780-1f386c64a-05bb-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5756-12023-01-30C16284748780-1f386c64a-05bb-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5756-22023-01-30C16284748780-1f386c64a-05bb-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5756-32023-01-30C16284748780-1f386c64a-05bb-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5756-0Cyclobenzaprine hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011
50090-5756-1Cyclobenzaprine hydrochloride20 in 1 BOTTLETABLET, FILM COATED2011
50090-5756-2Cyclobenzaprine hydrochloride90 in 1 BOTTLETABLET, FILM COATED9011
50090-5756-3Cyclobenzaprine hydrochloride24 in 1 BOTTLETABLET, FILM COATED2411
50090-5756-4Cyclobenzaprine hydrochloride10 in 1 BOTTLETABLET, FILM COATED1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5756-0EA - Each50090-5756dae20783-278e-4818-a197-b6e54a3d868612022-10-06
50090-5756-1EA - Each50090-5756dac2e6f9-9bc1-4cdb-b369-a4518a32498212022-10-06
50090-5756-2EA - Each50090-57566032e659-812a-41ba-8567-c92e7a2d5bae12022-10-06
50090-5756-3EA - Each50090-575695dfc9c2-78c5-41a1-9e5d-0d884bcce59612022-10-06
50090-5756-4EA - Each50090-57566a005bce-dcaf-4f74-abfc-378c8bd4cf9712024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5756CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 5 package rows20240530_f2286776-a7de-42dc-b745-d250e741eeb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf2286776-a7de-42dc-b745-d250e741eeb611
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf2286776-a7de-42dc-b745-d250e741eeb611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5756-05009057560030 TABLET, FILM COATED in 1 BOTTLE (50090-5756-0) 2021-10-010000-00-00NoNoCurrent
50090-5756-15009057560120 TABLET, FILM COATED in 1 BOTTLE (50090-5756-1) 2021-10-010000-00-00NoNoCurrent
50090-5756-25009057560290 TABLET, FILM COATED in 1 BOTTLE (50090-5756-2) 2021-10-010000-00-00NoNoCurrent
50090-5756-35009057560324 TABLET, FILM COATED in 1 BOTTLE (50090-5756-3) 2021-11-010000-00-00NoNoCurrent
50090-5756-45009057560410 TABLET, FILM COATED in 1 BOTTLE (50090-5756-4) 2024-05-17NoNoHistorical