Cyclobenzaprine Hydrochloride

Product NDC
63187-590
11-digit product format
631870590
Labeler code
63187
Product ID
63187-590_dfd6a8bf-5460-47a3-9865-ec043cd9d17e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078722
Marketing category
ANDA
Marketing start
2015-03-25
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299

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
63187-590-09Cyclobenzaprine Hydrochloride9 in 1 BOTTLETABLET, FILM COATED96
63187-590-14Cyclobenzaprine Hydrochloride14 in 1 BOTTLETABLET, FILM COATED146
63187-590-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED206
63187-590-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
63187-590-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED606
63187-590-72Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1206
63187-590-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-590-14EA - Each63187-590f3d2393e-0602-4b01-bbd9-37414ad4ca5d12024-12-10
63187-590-20EA - Each63187-5907aacb400-c6b2-48cf-bb01-51edca9443e712024-10-04
63187-590-30EA - Each63187-5900d69d697-17ae-497d-9781-5e1836fbd68e12017-03-06
63187-590-60EA - Each63187-590c8d5b9d6-6b86-4532-9c27-adea55d4a76512016-04-04
63187-590-72EA - Each63187-590aa440d9c-cd69-4a54-a4be-0f832352dc6a12024-06-10
63187-590-90EA - Each63187-590e64edc88-3b42-4ee6-83ce-67e20dcc4d0d12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-590CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 7 package rows20240907_ae3a3f5c-fb64-4a43-be88-a2fc7c298ac1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNae3a3f5c-fb64-4a43-be88-a2fc7c298ac16
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDae3a3f5c-fb64-4a43-be88-a2fc7c298ac16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-590-09631870590099 TABLET, FILM COATED in 1 BOTTLE (63187-590-09) 2026-05-13NoNoHistorical
63187-590-106318705901010 TABLET, FILM COATED in 1 BOTTLE (63187-590-10) 2018-12-010000-00-00NoNoCurrent
63187-590-146318705901414 TABLET, FILM COATED in 1 BOTTLE (63187-590-14) 2024-09-04NoNoHistorical
63187-590-156318705901515 TABLET, FILM COATED in 1 BOTTLE (63187-590-15) 2018-12-010000-00-00NoNoCurrent
63187-590-206318705902020 TABLET, FILM COATED in 1 BOTTLE (63187-590-20) 2018-12-010000-00-00NoNoCurrent
63187-590-216318705902121 TABLET, FILM COATED in 1 BOTTLE (63187-590-21) 2018-12-010000-00-00NoNoCurrent
63187-590-306318705903030 TABLET, FILM COATED in 1 BOTTLE (63187-590-30) 2018-12-010000-00-00NoNoCurrent
63187-590-456318705904545 TABLET, FILM COATED in 1 BOTTLE (63187-590-45) 2018-12-010000-00-00NoNoCurrent
63187-590-606318705906060 TABLET, FILM COATED in 1 BOTTLE (63187-590-60) 2018-12-010000-00-00NoNoCurrent
63187-590-7263187059072120 TABLET, FILM COATED in 1 BOTTLE (63187-590-72) 2018-12-010000-00-00NoNoCurrent
63187-590-7863187059078180 TABLET, FILM COATED in 1 BOTTLE (63187-590-78) 2018-12-010000-00-00NoNoCurrent
63187-590-906318705909090 TABLET, FILM COATED in 1 BOTTLE (63187-590-90) 2018-12-010000-00-00NoNoCurrent