FDA.reportPublic FDA data

NDC 68382-471-30 - telmisartan

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
68382-471
Requested NDC
68382-471-30
Package NDCs from labels
68382-471-30, 68382-471-78, 68382-471-06, 68382-471-16, 68382-471-01, 68382-471-05, 68382-471-10
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2023-11-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
telmisartan - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2023-11-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-471-01telmisartan100 in 1 BOTTLETABLET10010
68382-471-05telmisartan500 in 1 BOTTLETABLET50010
68382-471-06telmisartan30 in 1 BOTTLETABLET3010
68382-471-10telmisartan1000 in 1 BOTTLETABLET100010
68382-471-16telmisartan90 in 1 BOTTLETABLET9010
68382-471-30telmisartan1 in 1 BLISTER PACKTABLET110
68382-471-78telmisartan30 in 1 CARTONTABLET3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-471TELMISARTAN TABLET [ZYDUS PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 7 package rows20231110_e61c209a-4fc3-4f5c-b526-6412f0b8897c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-471-30EA - Each68382-4718c628bab-56d7-40a2-a374-b9d437d03b0d12017-04-05
68382-471-78EA - Each68382-471953dd1d5-32c8-4398-b090-6d492994ad6e12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TELMISARTANACTIVE INGREDIENTU5SYW473RQTELMISARTAN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
TELMISARTANACTIVE MOIETYU5SYW473RQTELMISARTAN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TELMISARTAN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTELMISARTAN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TELMISARTAN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYTELMISARTAN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ETELMISARTAN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITELMISARTAN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITELMISARTAN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RTELMISARTAN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3

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 2 of 10 · 185 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
telmisartanTELMISARTANREMEDYREPACK INC.09d31eee-cd22-4918-a889-3eb4d29695252026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205305
unii: U5SYW473RQ
TelmisartanTELMISARTANAlembic Pharmaceuticals Limited4be6575f-ea8d-4cd8-a49d-3d1c93f2621a2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
TelmisartanTELMISARTANAlembic Pharmaceuticals Inc.c62d424c-7630-413c-be2c-3932831c3f1d2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
TelmisartanTELMISARTANBryant Ranch Prepack830741dd-3f3c-4f8e-88c6-dc112166f4772026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205305
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepacka5ded796-3555-4476-8b37-0cdc88d7594a2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepackc55e4fe1-f04d-4995-a706-9f432fde57e42026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205305
unii: U5SYW473RQ
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 506T60A25R
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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