FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
63187-812
11-digit product format
631870812
Labeler code
63187
Product ID
63187-812_3afe19fb-b693-47f7-a08e-a46cc756ffda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
Rxcui828348

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
63187-812-07Cyclobenzaprine Hydrochloride7 in 1 BOTTLETABLET, FILM COATED79
63187-812-10Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED109
63187-812-12Cyclobenzaprine Hydrochloride12 in 1 BOTTLETABLET, FILM COATED129
63187-812-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED159
63187-812-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED209
63187-812-21Cyclobenzaprine Hydrochloride21 in 1 BOTTLETABLET, FILM COATED219
63187-812-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED309
63187-812-45Cyclobenzaprine Hydrochloride45 in 1 BOTTLETABLET, FILM COATED459
63187-812-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED609
63187-812-72Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1209
63187-812-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-812-07EA - Each63187-8121ff17e93-323b-4bdc-8e1d-3c3a9b542c2012021-07-15
63187-812-10EA - Each63187-8123218df58-35ff-4596-be00-efc94179fb5612017-10-13
63187-812-12EA - Each63187-8127a5d5855-8ec3-4d65-8e93-b345563fe12a12018-06-11
63187-812-15EA - Each63187-812b7e726b3-9afb-459b-862d-174e8ddfaa9112017-04-05
63187-812-20EA - Each63187-812c314774b-7b52-4bdb-bcb3-6d52f86e596212017-04-05
63187-812-21EA - Each63187-812b2e4eb6b-24c5-4087-8847-13a844d58be012017-04-05
63187-812-30EA - Each63187-81237819cb4-3e2f-4af0-ac91-16f5c7e5927d12017-04-05
63187-812-45EA - Each63187-812a8c71524-6281-4b91-8831-6717874cd3c012017-04-05
63187-812-60EA - Each63187-8128a6a2446-15f2-4abe-80ea-b56e14cdd90612017-04-05
63187-812-72EA - Each63187-812a468a908-6e15-4fc7-82c0-48ea88559b8b12023-08-08
63187-812-90EA - Each63187-812b9d3aef6-0c67-401c-b5ab-c95a321ad90312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-812CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [PROFICIENT RX LP]9Current NDC, Legacy NDC, 11 package rows20220413_ae6de8d8-33c2-40bd-9dd3-782c879a9d8f.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-812-07631870812077 TABLET, FILM COATED in 1 BOTTLE (63187-812-07) 2021-05-140000-00-00NoNoCurrent
63187-812-106318708121010 TABLET, FILM COATED in 1 BOTTLE (63187-812-10) 2017-08-010000-00-00NoNoCurrent
63187-812-126318708121212 TABLET, FILM COATED in 1 BOTTLE (63187-812-12) 2018-04-020000-00-00NoNoCurrent
63187-812-156318708121515 TABLET, FILM COATED in 1 BOTTLE (63187-812-15) 2017-02-020000-00-00NoNoCurrent
63187-812-206318708122020 TABLET, FILM COATED in 1 BOTTLE (63187-812-20) 2017-02-020000-00-00NoNoCurrent
63187-812-216318708122121 TABLET, FILM COATED in 1 BOTTLE (63187-812-21) 2017-02-010000-00-00NoNoCurrent
63187-812-306318708123030 TABLET, FILM COATED in 1 BOTTLE (63187-812-30) 2017-02-010000-00-00NoNoCurrent
63187-812-456318708124545 TABLET, FILM COATED in 1 BOTTLE (63187-812-45) 2017-02-010000-00-00NoNoCurrent
63187-812-606318708126060 TABLET, FILM COATED in 1 BOTTLE (63187-812-60) 2017-02-010000-00-00NoNoCurrent
63187-812-7263187081272120 TABLET, FILM COATED in 1 BOTTLE (63187-812-72) 2018-02-010000-00-00NoNoCurrent
63187-812-906318708129090 TABLET, FILM COATED in 1 BOTTLE (63187-812-90) 2017-02-010000-00-00NoNoCurrent