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
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 | 71068-001 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 71068-001 | 71068-001-10 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 71068-001 | 71068-001-11 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 71068-001 | 71068-001-98 | 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 |
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71068-001-10 | 2022-01-31 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
| 71068-001-11 | 2022-01-31 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
| 71068-001-98 | 2022-01-31 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
| 71068-001-10 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
| 71068-001-11 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
| 71068-001-98 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
| 71068-001-10 | 2020-02-14 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
| 71068-001-11 | 2020-02-14 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
| 71068-001-98 | 2020-02-14 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
| 71068-001-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
| 71068-001-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
| 71068-001-98 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c40f-f424-e053-dadaa90a57ce | 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 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71068-001-10 | 71068000110 | 1 BLISTER PACK in 1 CARTON (71068-001-10) > 12 TABLET, DELAYED RELEASE in 1 BLISTER PACK (71068-001-00) | 1 blister pack | 2019-02-01 | 2022-04-01 | No | No | Current |
| 71068-001-11 | 71068000111 | 3 BLISTER PACK in 1 CARTON (71068-001-11) > 12 TABLET, DELAYED RELEASE in 1 BLISTER PACK (71068-001-00) | 3 blister pack | 2019-02-01 | 0000-00-00 | No | No | Current |
| 71068-001-98 | 71068000198 | 1 BLISTER PACK in 1 CARTON (71068-001-98) > 12 TABLET, DELAYED RELEASE in 1 BLISTER PACK (71068-001-88) | 1 blister pack | 2019-02-01 | 0000-00-00 | Yes | No | Current |