Home NDC 71068-001-98 Aemcolo
Product NDC 71068-001
Requested package NDC 71068-001-98
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
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# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210910-001 NCE 2023-11-16 N210910-001 GAIN 2028-11-16
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N210910-001 AEMCOLO EQ 194MG BASE TABLET, DELAYED RELEASE / ORAL RLD 2018-11-16 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N210910-001 NCE 2023-11-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N210910-001 GAIN 2028-11-16 a50c72e98297…
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 71068-001-98 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