Erythromycin
Approved
Approval ID
3e823928-c853-4617-acad-21b27174aa7b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 29, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erythromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1386
Application NumberANDA061621
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2010
FDA Product Classification
INGREDIENTS (18)
ERYTHROMYCINActive
Quantity: 250 mg in 1 1
Code: 63937KV33D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
Erythromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1387
Application NumberANDA061621
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2010
FDA Product Classification
INGREDIENTS (18)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ERYTHROMYCINActive
Quantity: 500 mg in 1 1
Code: 63937KV33D
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT