NDC 71068-001
Aemcolo
Rifamycin
Aemcolo is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Aries Pharmaceuticals Inc. The primary component is Rifamycin.
| Product ID | 71068-001_26da6102-f851-4f4b-a605-bcb417a377a7 |
| NDC | 71068-001 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Aemcolo |
| Generic Name | Rifamycin |
| Dosage Form | Tablet, Delayed Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-02-01 |
| Marketing End Date | 2022-04-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA210910 |
| Labeler Name | Aries Pharmaceuticals Inc |
| Substance Name | RIFAMYCIN |
| Active Ingredient Strength | 194 mg/1 |
| Pharm Classes | Rifamycin Antibacterial [EPC], Rifamycins [CS] |
| NDC Exclude Flag | N |
Packaging
NDC 71068-001-10
1 BLISTER PACK in 1 CARTON (71068-001-10) > 12 TABLET, DELAYED RELEASE in 1 BLISTER PACK (71068-001-00)
| Marketing Start Date | 2019-02-01 |
| Marketing End Date | 2022-04-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 71068-001-88 [71068000188]
Aemcolo TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA210910 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-01 |
NDC 71068-001-10 [71068000110]
Aemcolo TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA210910 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-02-01 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-14 |
NDC 71068-001-00 [71068000100]
Aemcolo TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA210910 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-02-01 |
NDC 71068-001-11 [71068000111]
Aemcolo TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA210910 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-02-01 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-14 |
NDC 71068-001-98 [71068000198]
Aemcolo TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA210910 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-01 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-14 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| RIFAMYCIN | 194 mg/1 |
OpenFDA Data
| SPL SET ID: | 509338f4-a1b3-4c10-a3cb-7fb03fd01f12 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Aemcolo" or generic name "Rifamycin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 57841-1200 | Aemcolo | Rifamycin |
| 57841-1201 | Aemcolo | Rifamycin |
| 71068-001 | Aemcolo | Rifamycin |
Trademark Results [Aemcolo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AEMCOLO 87774308 not registered Live/Pending |
Cosmo Technologies Ltd 2018-01-29 |
 AEMCOLO 87593590 not registered Live/Pending |
Cosmo Technologies Ltd 2017-09-01 |
 AEMCOLO 87119637 5885718 Live/Registered |
Cosmo Technologies Ltd 2016-07-28 |
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