Aemcolo
- Product NDC
- 57841-1200
- 11-digit product format
- 578411200
- Labeler code
- 57841
- Product ID
- 57841-1200_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 NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57841-1200-1 | 57841120001 | 2 BLISTER PACK in 1 CARTON (57841-1200-1) > 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) | 2 blister pack | 2021-07-01 | 0000-00-00 | No | No | Current |
| 57841-1200-2 | 57841120002 | 6 BLISTER PACK in 1 CARTON (57841-1200-2) > 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) | 6 blister pack | 2021-07-01 | 0000-00-00 | No | No | Current |