FDA.reportPublic FDA data

NDC 13668-658-13 - Sirolimus

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
13668-658
Requested NDC
13668-658-13
Package NDCs from labels
13668-658-13, 13668-658-87
Manufacturer
Torrent pharmaceuticals limited | Torrent Pharma, Inc. | Cambrex Pharmaceutical
Effective date
2022-01-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sirolimus - Torrent pharmaceuticals limited | Torrent Pharma, Inc. | Cambrex PharmaceuticalTorrent pharmaceuticals limited | Torrent Pharma, Inc. | Cambrex Pharmaceutical2022-01-03HUMAN PRESCRIPTION DRUG LABEL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 7 · 128 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalmart, Inc.deebaf7f-f20d-4d7f-e053-2a95a90a4b4f2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
CorneaCare Recover Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCorneaCare Inc.1fd3a5ed-8963-5c8e-e063-6394a90a65272025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
unii: 6DC9Q167V3
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
SirolimusSIROLIMUSMajor Pharmaceuticals1bef7d8f-524b-4218-8fef-6c3f3628d33e2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W36ZG6FT64
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: 6DC9Q167V3
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
unii: 6DC9Q167V3
SirolimusSIROLIMUSRising Pharma Holdings, Inc.400da0a5-2a85-44ab-a2c5-bb9161750db32025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W36ZG6FT64
SirolimusSIROLIMUSAscend Laboratories, LLCcdc49844-3e77-41d3-8287-b16d0c4742c52025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W36ZG6FT64
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: 6DC9Q167V3
sirolimusSIROLIMUSNorthstar Rx LLC848b53ea-cdb6-45f8-bc70-8600d2dd6dce2025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W36ZG6FT64
HYFTORSIROLIMUSNobelpharma America, LLCedb3ea90-5adc-48ec-99f5-ab963e302f182025-08-22Warnings, Adverse reactionsExact identifier
unii: W36ZG6FT64
SirolimusSIROLIMUSAmerican Health Packaging5df60452-2b16-4ce9-8c29-48798a59d7182025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W36ZG6FT64
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.