FDA.reportPublic FDA data

NDC 52959-910-30 - Hypertenipine

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
52959-910
Requested NDC
52959-910-30
Package NDCs from labels
52959-910-30
Manufacturer
Physician Therapeutics LLC | InvaGen Pharmaceuticals, Inc | H.J. Harkins Company, Inc. | Targeted Medical Pharma, Inc.
Effective date
2011-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hypertenipine-2.5Physician Therapeutics LLC | InvaGen Pharmaceuticals, Inc | H.J. Harkins Company, Inc. | Targeted Medical Pharma, Inc.2011-08-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-910-30Hypertenipine30 in 1 BOTTLETABLET302.5 mg7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-910HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7Unmatched20110812_2fcc87a4-74ef-46bd-8ee9-bd2f3cf3d0c2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
ARGININEACTIVE INGREDIENT94ZLA3W45FHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
AMLODIPINEACTIVE MOIETY1J444QC288HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
ARGININEACTIVE MOIETY94ZLA3W45FHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
GELATININACTIVE INGREDIENT2G86QN327LHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7

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 13 of 15 · 288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsf77db79c-c998-4b63-9984-4cf245f188a72023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCd830173d-7676-4490-ab3d-d3515df9ad2e2023-09-07Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee12023-09-07Warnings, Adverse reactionsExact identifier
application number: ANDA077955
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions69a887ab-95cd-4b81-80ee-02e20eebf65b2023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AzorAMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMILCosette Pharmaceuticals, Inc.c5535406-b63b-49aa-88b9-169aaf0ed08e2023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
TribenzorOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDECosette Pharmaceuticals, Inc.2f56d0bc-236b-41a0-9fc0-21cdfea8d8902023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
A L O FormulaCHOLINUM, L-ARGININE, L-CARNITINE, L-ORNITHINE, PANTOTHENIC ACIDNutritional Specialties, Inc.0df7e08c-c17f-4e5e-acfd-05f8af7277cc2023-07-07WarningsExact identifier
unii: 94ZLA3W45F
Vital Skin Hair NailsL-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.3e8a9233-6e65-4023-b3f8-8bca369a9c2a2023-06-15WarningsExact identifier
unii: 94ZLA3W45F
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LPced6d26e-8c54-4808-88b6-446344f4acd02023-06-01Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC186b6149-9610-4380-9bf2-9416460692762023-05-04Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBluePoint Laboratoriesdf8e23c8-6c8f-4293-8a37-5ad3d48dba942023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCb597d1e1-aba1-4272-bed7-4c95e8150d582023-04-19Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEExelan Pharmaceuticals, Inc.efd9eda5-f497-45a3-ae13-dee729add9992023-03-23Warnings, Adverse reactionsExact identifier
application number: ANDA077955
rxcui: 308136
unii: 864V2Q084H
NorvascAMLODIPINE BESYLATEViatris Specialty LLC7367289c-b0b0-466a-83e2-558e2985c29f2023-02-15Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
CellTropinARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUSMicro Balance Health Products LLC502d3ffa-bbf4-403a-9fad-b6b229f36a8c2023-02-14WarningsExact identifier
unii: 94ZLA3W45F
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEAlembic Pharmaceuticals Limited15b438b4-4874-43f4-a50a-4e6f3e5530ac2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and ValsartanAMLODIPINE AND VALSARTANAlembic Pharmaceuticals Limiteda9c442dc-749e-4de0-bca3-1044eb78da722023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylate and Olmesartran medoxomilAMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMILAlembic Pharmaceuticals Limitedcb2df7f7-fee8-42ba-8936-0788c4fcc0cb2023-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDr.Reddy's Laboratories Limitedf12f18bb-7ddb-e7dc-4edd-32f4ac212bca2022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDr.Reddy's Laboratories Limitedca014f06-982c-6fe1-9948-a3701dd35d342022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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