Aemcolo

Product NDC
71068-001
11-digit product format
710680001
Labeler code
71068
Product ID
71068-001_26da6102-f851-4f4b-a605-bcb417a377a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rifamycin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aries Pharmaceuticals Inc
Application
NDA210910
Marketing category
NDA
Marketing start
2019-02-01
Marketing end
2022-04-01
Substance
RIFAMYCIN
Active strength
194 mg/1
Pharmacologic classes
Rifamycin Antibacterial [EPC], Rifamycins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71068-001-00EA - Each71068-001379ff924-265e-4aad-b9c3-4e019a84a5e712019-01-24
71068-001-10EA - Each71068-001993f3bf6-af9c-419e-b796-53e02977d8bc12019-01-24
71068-001-11EA - Each71068-001d55edb25-d89e-4aa8-b48a-4344c4b3961312019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71068-001-10710680001101 BLISTER PACK in 1 CARTON (71068-001-10) > 12 TABLET, DELAYED RELEASE in 1 BLISTER PACK (71068-001-00) 1 blister pack2019-02-012022-04-01NoNoCurrent
71068-001-11710680001113 BLISTER PACK in 1 CARTON (71068-001-11) > 12 TABLET, DELAYED RELEASE in 1 BLISTER PACK (71068-001-00) 3 blister pack2019-02-010000-00-00NoNoCurrent
71068-001-98710680001981 BLISTER PACK in 1 CARTON (71068-001-98) > 12 TABLET, DELAYED RELEASE in 1 BLISTER PACK (71068-001-88) 1 blister pack2019-02-010000-00-00YesNoCurrent