Cyclobenzaprine Hydrochloride

Product NDC
70934-005
11-digit product format
709340005
Labeler code
70934
Product ID
70934-005_b8a72eaa-6f3d-458d-e053-2a95a90aa50f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA090478
Marketing category
ANDA
Marketing start
2017-02-21
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-005-10Cyclobenzaprine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED105
70934-005-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED155
70934-005-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED205
70934-005-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-005CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]5Legacy NDC, 4 package rows20210131_77f5c98e-9196-31d6-e053-2a91aa0a5205.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN77f5c98e-9196-31d6-e053-2a91aa0a52055
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD77f5c98e-9196-31d6-e053-2a91aa0a52055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-005-107093400051010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-005-10) 2017-03-090000-00-00NoNoCurrent
70934-005-157093400051515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-005-15) 2018-07-090000-00-00NoNoCurrent
70934-005-207093400052020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-005-20) 2019-03-120000-00-00NoNoCurrent
70934-005-307093400053030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-005-30) 2017-02-210000-00-00NoNoCurrent