Aemcolo

Product NDC
57841-1201
11-digit product format
578411201
Labeler code
57841
Product ID
57841-1201_2896e337-7410-4532-bea3-f0a65ef7135a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rifamycin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
RedHill Biopharma Ltd
Application
NDA210910
Marketing category
NDA
Marketing start
2021-07-01
Marketing end
0000-00-00
Substance
RIFAMYCIN
Active strength
194 mg/1
Pharmacologic classes
Rifamycin Antibacterial [EPC], Rifamycins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57841-1201-1578411201011 BLISTER PACK in 1 CARTON (57841-1201-1) > 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1201-0) 1 blister pack2021-07-010000-00-00NoNoCurrent