FDA.reportPublic FDA data

Aemcolo

Product NDC
57841-1200
Requested package NDC
57841-1200-2
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57841-120057841-1200-2DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210910-001AEMCOLORIFAMYCIN SODIUMEQ 194MG BASETABLET, DELAYED RELEASE / ORALRLD2018-11-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N210910-001NCE2023-11-16
N210910-001GAIN2028-11-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N210910-001AEMCOLOEQ 194MG BASETABLET, DELAYED RELEASE / ORALRLD2018-11-16a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N210910-001NCE2023-11-16a50c72e98297…
2026-08-01 22:54:322026-06N210910-001GAIN2028-11-16a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57841-1200-1EA - Each57841-1200cd91161f-f222-42c7-8622-de8920766c0c12021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57841-1200-2578411200026 BLISTER PACK in 1 CARTON (57841-1200-2) > 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) 6 blister pack2021-07-010000-00-00NoNoCurrent