FDA.reportPublic FDA data

NDC 42291-464-11 - Telmisartan and Hydrochlorothiazide

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
42291-464
Requested NDC
42291-464-11
Package NDCs from labels
42291-464-11, 42291-464-30
Manufacturer
AvKARE
Effective date
2026-09-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Telmisartan and Hydrochlorothiazide - AvKAREAvKARE2026-09-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-464-11Telmisartan and Hydrochlorothiazide10 in 1 BLISTER PACKTABLET102
42291-464-30Telmisartan and Hydrochlorothiazide3 in 1 BOXTABLET32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-464TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [AVKARE]1Current NDC, 2 package rows20240620_1b303136-dccd-178b-e063-6394a90a35f8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-464-11EA - Each42291-464531cd384-6ad8-48d2-a4d6-f57b6abf8b9a12024-07-12
42291-464-30EA - Each42291-4644ba76b97-d555-45f6-b034-ee4afbf8dfe812024-07-12

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 8 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSPreferred Pharmaceuticals Inc.5956a107-0f7b-49e7-b9c9-36790349b06e2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals, Inc.5aa18b0b-4688-493a-a5ae-cb056ea6c0e32026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSPreferred Pharmaceuticals Inc.9207c3bc-e12e-4017-8b85-0f928e744f642026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSPreferred Pharmaceuticals Inc.fc4d7d0e-78a6-4d7e-ba53-aeeb008aa2dc2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEScieGen Pharmaceuticals Inc52332190-2a12-d205-e063-6394a90ab7c52026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANBryant Ranch Prepack830741dd-3f3c-4f8e-88c6-dc112166f4772026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepacka5ded796-3555-4476-8b37-0cdc88d7594a2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack77e71a2e-8370-4f7a-a5e4-93d86bd37dad2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack544b75eb-55f1-4164-9b83-39f6bc5fb4792026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackc5258ea3-3aac-48fd-be5a-f8e4a47ca94a2026-05-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANBryant Ranch Prepackc55e4fe1-f04d-4995-a706-9f432fde57e42026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepacka013211e-b8f8-426d-8e55-e86193f0634e2026-05-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackf22a10a2-8f84-4060-9143-427237c512802026-05-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf3bc491a-961d-4a38-8a55-c4a03be05b742026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepacke6c35575-9c3f-42f8-b8b8-577a29f9d3812026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack2b21f3fc-4164-401a-803e-b982dea97e192026-05-14Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.27a7e751-8aca-440e-95e4-cfecae1a24652026-05-13Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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