Demeclocycline Hydrochloride
Demeclocycline Hydrochloride Tablets Rx Only
Approved
Approval ID
88e03cb0-25f5-41a5-b77f-58ab8f3be181
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2019
Manufacturers
FDA
PuraCap Laboratories LLC
DUNS: 080210964
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Demeclocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24658-710
Application NumberANDA065447
Product Classification
M
Marketing Category
C73584
G
Generic Name
Demeclocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2019
FDA Product Classification
INGREDIENTS (19)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE L)Inactive
Code: UKE75GEA7F
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
DEMECLOCYCLINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 29O079NTYT
Classification: ACTIB
Demeclocycline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24658-711
Application NumberANDA065447
Product Classification
M
Marketing Category
C73584
G
Generic Name
Demeclocycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2019
FDA Product Classification
INGREDIENTS (19)
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE L)Inactive
Code: UKE75GEA7F
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
DEMECLOCYCLINE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 29O079NTYT
Classification: ACTIB