FDA.reportPublic FDA data

Demeclocycline Hydrochloride

Product NDC
60687-705
11-digit product format
606870705
Labeler code
60687
Product ID
60687-705_230a18ee-ef80-61c6-e063-6394a90acb5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Demeclocycline
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA065425
Marketing category
ANDA
Marketing start
2023-01-19
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
60687-705-11Demeclocycline Hydrochloride1 in 1 BLISTER PACKTABLET14
60687-705-65Demeclocycline Hydrochloride50 in 1 CARTONTABLET504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-705-11EA - Each60687-7051249533c-3e53-40b6-a57e-c33b2ded596712022-12-07
60687-705-65EA - Each60687-70534e7e261-28c8-4654-9f83-89e48efcd4c812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-705DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 2 package rows20240927_e6adaf70-5ff9-4395-bff1-0f332090cb80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905341demeclocycline HCl 150 MG Oral TabletPSNe6adaf70-5ff9-4395-bff1-0f332090cb804
905347demeclocycline HCl 300 MG Oral TabletPSNe6adaf70-5ff9-4395-bff1-0f332090cb804
905341demeclocycline hydrochloride 150 MG Oral TabletSCDe6adaf70-5ff9-4395-bff1-0f332090cb804
905347demeclocycline hydrochloride 300 MG Oral TabletSCDe6adaf70-5ff9-4395-bff1-0f332090cb804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-705-11606870705111 in 1 BLISTER PACKHistorical
60687-705-656068707056550 BLISTER PACK in 1 CARTON (60687-705-65) / 1 TABLET in 1 BLISTER PACK (60687-705-11) 50 blister pack2023-01-190000-00-00NoNoCurrent