Demeclocycline Hydrochloride

Product NDC
24658-711
11-digit product format
246580711
Labeler code
24658
Product ID
24658-711_aa40e353-18db-4553-8f8d-a434eac8ed1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Demeclocycline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PuraCap Laboratories LLC
Application
ANDA065447
Marketing category
ANDA
Marketing start
2017-10-07
Substance
DEMECLOCYCLINE HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Demeclocycline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEMECLOCYCLINE HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii29O079NTYT
Rxcui905341, 905347

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b5dbb1ae-e36f-978d-e5e0-8711031739bcProduct name220150904

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24658-711-48Demeclocycline Hydrochloride48 in 1 BOTTLETABLET, FILM COATED486

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-711-48EA - Each24658-711b99e8c8f-0253-4a1a-957a-3771d3320c6d12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-711DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [PURACAP LABORATORIES LLC]5Current NDC, Legacy NDC, 1 package rows20241222_88e03cb0-25f5-41a5-b77f-58ab8f3be181.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905341demeclocycline HCl 150 MG Oral TabletPSN88e03cb0-25f5-41a5-b77f-58ab8f3be1816
905347demeclocycline HCl 300 MG Oral TabletPSN88e03cb0-25f5-41a5-b77f-58ab8f3be1816
905341demeclocycline hydrochloride 150 MG Oral TabletSCD88e03cb0-25f5-41a5-b77f-58ab8f3be1816
905347demeclocycline hydrochloride 300 MG Oral TabletSCD88e03cb0-25f5-41a5-b77f-58ab8f3be1816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24658-711-482465807114848 TABLET, FILM COATED in 1 BOTTLE (24658-711-48) 2017-10-070000-00-00NoNoCurrent