FDA.reportPublic FDA data

Demeclocycline Hydrochloride

Product NDC
65162-555
11-digit product format
651620555
Labeler code
65162
Product ID
65162-555_4cd13048-b500-48bc-b998-e47aafff605e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Demeclocycline
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA065425
Marketing category
ANDA
Marketing start
2008-02-27
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
65162-555-48Demeclocycline Hydrochloride48 in 1 BOTTLETABLET4814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-555-48EA - Each65162-555dbc248fa-2cec-4f48-9c8e-2bef3e4b820612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEMECLOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT29O079NTYTDEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
DEMECLOCYCLINEACTIVE MOIETY5R5W9ICI6ODEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZDEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KDEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UDEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-555DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS LLC]14Current NDC, Legacy NDC, 1 package rows20241027_4ff23e3b-e111-47fd-9776-1d89d6da049b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905341demeclocycline HCl 150 MG Oral TabletPSN4ff23e3b-e111-47fd-9776-1d89d6da049b14
905347demeclocycline HCl 300 MG Oral TabletPSN4ff23e3b-e111-47fd-9776-1d89d6da049b14
905341demeclocycline hydrochloride 150 MG Oral TabletSCD4ff23e3b-e111-47fd-9776-1d89d6da049b14
905347demeclocycline hydrochloride 300 MG Oral TabletSCD4ff23e3b-e111-47fd-9776-1d89d6da049b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-555-486516205554848 TABLET in 1 BOTTLE (65162-555-48) 48 tablet2008-02-270000-00-00NoNoCurrent