FDA.reportPublic FDA data

NDC 0088-2100-03 - Priftin

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
0088-2100
Requested NDC
0088-2100-03
Package NDCs from labels
0088-2100-24, 0088-2100-32, 0088-2100-03
Manufacturer
sanofi-aventis U.S. LLC | Sanofi S.p.A | Sanofi S.p.A (also known as Sanofi-Aventis S.p.A)
Effective date
2020-07-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Priftinsanofi-aventis U.S. LLC | Sanofi S.p.A | Sanofi S.p.A (also known as Sanofi-Aventis S.p.A)2020-07-06HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0088-2100-03EA - Each0088-210012a2d658-aa6f-4143-8622-8c56327554ed12012-07-24
0088-2100-24EA - Each0088-2100165ff53e-f0a4-4503-808b-79bc5963c6c312015-10-02
0088-2100-32EA - Each0088-210012ce2da4-21ce-44e1-8cc8-d617dfc636e912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
rifapentineACTIVE INGREDIENTXJM390A33UPRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
rifapentineACTIVE MOIETYXJM390A33UPRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
aluminum oxideINACTIVE INGREDIENTLMI26O6933PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
calcium stearateINACTIVE INGREDIENT776XM7047LPRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKPRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
ferric oxide redINACTIVE INGREDIENT1K09F3G675PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PPRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1APRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
sodium ascorbateINACTIVE INGREDIENTS033EH8359PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JPRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]15

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 1 of 116 · 2,306 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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