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
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 57841-1200 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 57841-1200 | 57841-1200-1 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 57841-1200 | 57841-1200-2 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| N210910-001 | AEMCOLO | RIFAMYCIN SODIUM | EQ 194MG BASE | TABLET, DELAYED RELEASE / ORAL | | RLD | 2018-11-16 |
Orange Book exclusivity#
Application-product, Exclusivity code, Expiration table| Application-product | Exclusivity code | Expiration |
|---|
| N210910-001 | NCE | 2023-11-16 |
| N210910-001 | GAIN | 2028-11-16 |
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 |