FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
50436-0400
11-digit product format
504360400
Labeler code
50436
Product ID
50436-0400_14b643ab-409c-443d-bc46-bb224e771280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077797
Marketing category
ANDA
Marketing start
2017-03-30
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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
50436-0400-12023-01-30C16284748780-1f386c64a-30c2-0266-e053-dadaa90a7c1aCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
50436-0400-22023-01-30C16284748780-1f386c64a-30c2-0266-e053-dadaa90a7c1aCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
50436-0400-32023-01-30C16284748780-1f386c64a-30c2-0266-e053-dadaa90a7c1aCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0400-1Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
50436-0400-2Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
50436-0400-3Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0400-1EA - Each50436-0400b8125e18-0753-484c-8294-28faf7827ce312021-12-08
50436-0400-2EA - Each50436-0400ea9c2445-0d5c-48f2-bbb6-93718782aac512021-12-08
50436-0400-3EA - Each50436-0400076b3552-7a91-4cab-99ca-b4771462e42912021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0400CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 3 package rows20211023_35fb2777-e4c5-41cb-8695-3ccabec4e0a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN35fb2777-e4c5-41cb-8695-3ccabec4e0a42
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD35fb2777-e4c5-41cb-8695-3ccabec4e0a42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0400-15043604000130 TABLET, FILM COATED in 1 BOTTLE (50436-0400-1) 2021-10-120000-00-00NoNoCurrent
50436-0400-25043604000260 TABLET, FILM COATED in 1 BOTTLE (50436-0400-2) 2021-10-120000-00-00NoNoCurrent
50436-0400-35043604000390 TABLET, FILM COATED in 1 BOTTLE (50436-0400-3) 2021-10-120000-00-00NoNoCurrent