Aemcolo
These highlights do not include all the information needed to use AEMCOLO safely and effectively. See full prescribing information for AEMCOLO. AEMCOLO (rifamycin) delayed-release tablets, for oral use. Initial U.S. Approval: 2018
Approved
Approval ID
b31ff668-ee1f-4d89-8b69-68df2a0d2243
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
RedHill Biopharma Ltd
DUNS: 533278342
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rifamycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57841-1201
Application NumberNDA210910
Product Classification
M
Marketing Category
C73594
G
Generic Name
Rifamycin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2021
FDA Product Classification
INGREDIENTS (14)
RifamycinActive
Quantity: 194 mg in 1 1
Code: DU69T8ZZPA
Classification: ACTIB
Ascorbic AcidInactive
Quantity: 20 mg in 1 1
Code: PQ6CK8PD0R
Classification: IACT
Ammonio methacrylate copolymer type BInactive
Quantity: 159 mg in 1 1
Code: 161H3B14U2
Classification: IACT
Magnesium stearateInactive
Quantity: 25 mg in 1 1
Code: 70097M6I30
Classification: IACT
Glyceryl distearateInactive
Quantity: 20 mg in 1 1
Code: 73071MW2KM
Classification: IACT
LECITHIN, SOYBEANInactive
Quantity: 10 mg in 1 1
Code: 1DI56QDM62
Classification: IACT
MANNITOLInactive
Quantity: 470 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Quantity: 150 mg in 1 1
Code: 5KY68S2577
Classification: IACT
Titanium DioxideInactive
Quantity: 2 mg in 1 1
Code: 15FIX9V2JP
Classification: IACT
Polyethylene glycol 6000Inactive
Quantity: 1 mg in 1 1
Code: 30IQX730WE
Classification: IACT
SILICON DIOXIDEInactive
Quantity: 15 mg in 1 1
Code: ETJ7Z6XBU4
Classification: IACT
TalcInactive
Quantity: 16.7 mg in 1 1
Code: 7SEV7J4R1U
Classification: IACT
Triethyl citrateInactive
Quantity: 2.3 mg in 1 1
Code: 8Z96QXD6UM
Classification: IACT
FERRIC OXIDE YELLOWInactive
Quantity: 6 mg in 1 1
Code: EX438O2MRT
Classification: IACT
Rifamycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57841-1200
Application NumberNDA210910
Product Classification
M
Marketing Category
C73594
G
Generic Name
Rifamycin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2021
FDA Product Classification
INGREDIENTS (14)
RifamycinActive
Quantity: 194 mg in 1 1
Code: DU69T8ZZPA
Classification: ACTIB
Ammonio methacrylate copolymer type BInactive
Quantity: 159 mg in 1 1
Code: 161H3B14U2
Classification: IACT
Ascorbic AcidInactive
Quantity: 20 mg in 1 1
Code: PQ6CK8PD0R
Classification: IACT
Glyceryl distearateInactive
Quantity: 20 mg in 1 1
Code: 73071MW2KM
Classification: IACT
LECITHIN, SOYBEANInactive
Quantity: 10 mg in 1 1
Code: 1DI56QDM62
Classification: IACT
Magnesium stearateInactive
Quantity: 25 mg in 1 1
Code: 70097M6I30
Classification: IACT
Polyethylene glycol 6000Inactive
Quantity: 1 mg in 1 1
Code: 30IQX730WE
Classification: IACT
MANNITOLInactive
Quantity: 470 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Quantity: 150 mg in 1 1
Code: 5KY68S2577
Classification: IACT
SILICON DIOXIDEInactive
Quantity: 15 mg in 1 1
Code: ETJ7Z6XBU4
Classification: IACT
TalcInactive
Quantity: 16.7 mg in 1 1
Code: 7SEV7J4R1U
Classification: IACT
Triethyl citrateInactive
Quantity: 2.3 mg in 1 1
Code: 8Z96QXD6UM
Classification: IACT
Titanium DioxideInactive
Quantity: 2 mg in 1 1
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Quantity: 6 mg in 1 1
Code: EX438O2MRT
Classification: IACT