Cyclobenzaprine

Product NDC
71205-897
11-digit product format
712050897
Labeler code
71205
Product ID
71205-897_895c4679-030d-47a8-96b0-394133d04998
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA071611
Marketing category
ANDA
Marketing start
2016-10-18
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-897-00EA - Each71205-897a91863de-97a8-4418-86a6-74897f0729da12021-09-07
71205-897-11EA - Each71205-8976c584d83-77ed-4ae7-a196-98f836b6a91312021-09-07
71205-897-30EA - Each71205-897b64e9df3-2c12-46d1-b42e-3cdf355e3b1112021-09-07
71205-897-55EA - Each71205-897fb9526d4-9ef8-4ef7-970d-ce5342f5e8cd12021-09-07
71205-897-60EA - Each71205-897892dd312-5f5b-428b-bed9-f01243b0ea0112021-09-07
71205-897-90EA - Each71205-897e797e99b-6502-467f-8954-191eaf5d309512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-897CYCLOBENZAPRINE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]2Legacy NDC20220413_e12bc92a-78e1-42f1-adfe-79df00292c57.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-897-0071205089700100 TABLET, FILM COATED in 1 BOTTLE (71205-897-00) 2021-08-020000-00-00NoNoCurrent
71205-897-11712050897111000 TABLET, FILM COATED in 1 BOTTLE (71205-897-11) 2021-08-020000-00-00NoNoCurrent
71205-897-307120508973030 TABLET, FILM COATED in 1 BOTTLE (71205-897-30) 2021-08-020000-00-00NoNoCurrent
71205-897-5571205089755500 TABLET, FILM COATED in 1 BOTTLE (71205-897-55) 2021-08-020000-00-00NoNoCurrent
71205-897-607120508976060 TABLET, FILM COATED in 1 BOTTLE (71205-897-60) 2021-08-020000-00-00NoNoCurrent
71205-897-907120508979090 TABLET, FILM COATED in 1 BOTTLE (71205-897-90) 2021-08-020000-00-00NoNoCurrent