Demeclocycline Hydrochloride

Product NDC
10135-625
11-digit product format
101350625
Labeler code
10135
Product ID
10135-625_5862ef81-aa7c-4331-96d5-ebc9bc9458d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Demeclocycline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA065447
Marketing category
ANDA
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
DEMECLOCYCLINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b5dbb1ae-e36f-978d-e5e0-8711031739bcProduct name220150904

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-625-012020-01-31C16284748780-19d75b9d1-11c4-f424-e053-dadaa90a57ceDemeclocycline Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-625-01Demeclocycline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-625-01EA - Each10135-625920daa4f-2752-4157-bcda-0b79a8581d0712016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-625DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 1 package rows20161006_10f80874-0289-4a23-8f42-b3e8fe43e1cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905341demeclocycline HCl 150 MG Oral TabletPSN10f80874-0289-4a23-8f42-b3e8fe43e1cb1
905347demeclocycline HCl 300 MG Oral TabletPSN10f80874-0289-4a23-8f42-b3e8fe43e1cb1
905341demeclocycline hydrochloride 150 MG Oral TabletSCD10f80874-0289-4a23-8f42-b3e8fe43e1cb1
905347demeclocycline hydrochloride 300 MG Oral TabletSCD10f80874-0289-4a23-8f42-b3e8fe43e1cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-625-0110135062501100 in 1 BOTTLEHistorical