FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
52817-332
11-digit product format
528170332
Labeler code
52817
Product ID
52817-332_b8c3dbd2-89f7-215b-e053-2995a90a7f74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TruPharma LLC
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
Rxcui828299, 828320, 828348

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
52817-332-00CYCLOBENZAPRINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10004
52817-332-10CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1004
52817-332-50CYCLOBENZAPRINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-332-00EA - Each52817-33294730440-210e-4f74-9de5-6bb90e35bcdc12018-06-11
52817-332-10EA - Each52817-3327a98d5f8-9389-41c6-a377-e18afd935ebc12019-01-24
52817-332-50EA - Each52817-3325f133973-c04a-44f7-aea8-667bf8455ab812018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-332CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [TRUPHARMA LLC]4Current NDC, Legacy NDC, 3 package rows20210114_08adc97f-feef-46fb-ac75-f015b4f3a43a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNeb908b77-741c-473a-b2e9-4f82167c308811
828348cyclobenzaprine HCl 10 MG Oral TabletPSN7b246152-e7a7-228c-e053-2a91aa0ad86311
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDeb908b77-741c-473a-b2e9-4f82167c308811
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD7b246152-e7a7-228c-e053-2a91aa0ad86311
828348cyclobenzaprine HCl 10 MG Oral TabletPSNafcab35f-4ab9-33a4-e053-2a95a90ad5298
828348cyclobenzaprine HCl 10 MG Oral TabletPSNa58cf759-048b-6740-e053-2a95a90a8b438
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4923ac1f-d463-465b-9e99-7312aef878618
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDafcab35f-4ab9-33a4-e053-2a95a90ad5298
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDa58cf759-048b-6740-e053-2a95a90a8b438
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4923ac1f-d463-465b-9e99-7312aef878618
828348cyclobenzaprine HCl 10 MG Oral TabletPSNd64ca498-81c6-4e10-ba82-3a50ee47bcfc6
828348cyclobenzaprine HCl 10 MG Oral TabletPSN88bdee56-d6d9-4f14-be77-1e6898ba36f56
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDd64ca498-81c6-4e10-ba82-3a50ee47bcfc6
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD88bdee56-d6d9-4f14-be77-1e6898ba36f56
828348cyclobenzaprine HCl 10 MG Oral TabletPSN06da53af-5b46-4e32-a64c-9677e27ae2295
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD06da53af-5b46-4e32-a64c-9677e27ae2295
828348cyclobenzaprine HCl 10 MG Oral TabletPSN85128989-bfa3-4b82-94c1-f90b14ccd2f94
828348cyclobenzaprine HCl 10 MG Oral TabletPSN08adc97f-feef-46fb-ac75-f015b4f3a43a4
828348cyclobenzaprine HCl 10 MG Oral TabletPSN8c66b5ed-f773-0779-e053-2995a90ad1f14
828348cyclobenzaprine HCl 10 MG Oral TabletPSNd4e0f532-887b-40bb-80d6-5c4e5b1d64bf4
828320cyclobenzaprine HCl 5 MG Oral TabletPSN85128989-bfa3-4b82-94c1-f90b14ccd2f94
828320cyclobenzaprine HCl 5 MG Oral TabletPSN08adc97f-feef-46fb-ac75-f015b4f3a43a4
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN08adc97f-feef-46fb-ac75-f015b4f3a43a4
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD85128989-bfa3-4b82-94c1-f90b14ccd2f94
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD8c66b5ed-f773-0779-e053-2995a90ad1f14
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD08adc97f-feef-46fb-ac75-f015b4f3a43a4
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDd4e0f532-887b-40bb-80d6-5c4e5b1d64bf4
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD85128989-bfa3-4b82-94c1-f90b14ccd2f94
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD08adc97f-feef-46fb-ac75-f015b4f3a43a4
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD08adc97f-feef-46fb-ac75-f015b4f3a43a4
828348cyclobenzaprine HCl 10 MG Oral TabletPSNb524d150-0a83-42d1-a884-b930e49760cd3
828348cyclobenzaprine HCl 10 MG Oral TabletPSNd6448bb1-9b8d-45f4-a14b-8328248e586e3
828348cyclobenzaprine HCl 10 MG Oral TabletPSN8bdc725e-22e3-0f32-e053-2a95a90ae8a93
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDb524d150-0a83-42d1-a884-b930e49760cd3
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDd6448bb1-9b8d-45f4-a14b-8328248e586e3
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD8bdc725e-22e3-0f32-e053-2a95a90ae8a93
828348cyclobenzaprine HCl 10 MG Oral TabletPSNdae3be94-a40c-5be1-e053-2a95a90a14842
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDdae3be94-a40c-5be1-e053-2a95a90a14842
828348cyclobenzaprine HCl 10 MG Oral TabletPSN26aa672e-cef1-dfef-e063-6394a90ae1c41
828348cyclobenzaprine HCl 10 MG Oral TabletPSN9aef6535-ab77-8ddf-e053-2995a90a66b91
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD26aa672e-cef1-dfef-e063-6394a90ae1c41
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD9aef6535-ab77-8ddf-e053-2995a90a66b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-332-00528170332001000 TABLET, FILM COATED in 1 BOTTLE (52817-332-00) 2017-05-310000-00-00NoNoCurrent
52817-332-1052817033210100 TABLET, FILM COATED in 1 BOTTLE (52817-332-10) 2017-05-310000-00-00NoNoCurrent
52817-332-5052817033250500 TABLET, FILM COATED in 1 BOTTLE (52817-332-50) 2017-05-310000-00-00NoNoCurrent