MedPath
FDA Approval

Demeclocycline Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
July 1, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Demeclocycline(300 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Demeclocycline Hydrochloride

Product Details

NDC Product Code
10135-626
Application Number
ANDA065447
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 5, 2016
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: 29O079NTYTClass: ACTIBQuantity: 300 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958Class: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYDROXYPROPYL CELLULOSE (TYPE L)Inactive
Code: UKE75GEA7FClass: IACT

Demeclocycline Hydrochloride

Product Details

NDC Product Code
10135-625
Application Number
ANDA065447
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 5, 2016
Code: 29O079NTYTClass: ACTIBQuantity: 150 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
HYDROXYPROPYL CELLULOSE (TYPE L)Inactive
Code: UKE75GEA7FClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
© Copyright 2025. All Rights Reserved by MedPath