FDA.reportPublic FDA data

NDC 52959-910 - 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
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 14 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Amlodipine BesylateAMLODIPINE BESYLATEUnichem Pharmaceuticals (USA), Inc.a516b336-8f60-4b86-8921-c7d6c07629f22022-12-05Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEProficient Rx LP29a0d87e-6afb-4766-9045-1963c5b0d1832022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCf3482709-c5c3-4bd0-8067-ad57f31bb5252022-10-18Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Premasol - sulfite-free (Amino Acid)LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDEBaxter Healthcare Company9afdcc3e-0d06-47f4-86ca-40da48b2b02b2022-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F
AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTANLupin Pharmaceuticals,Inc.e05dd72c-7475-422e-bf8e-73148929450e2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP445d1274-7249-476b-ad90-ff93aee56f6d2022-06-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d62022-04-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEExelan Pharmaceuticals, Inc.1a24433f-4464-4c6d-9456-ed1ce38e8ec42022-03-12Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
TH-101CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROBTemple Health Nutrition, LLCd54bb860-560c-4f8f-9aea-a0b7774cc92b2021-12-29WarningsExact identifier
unii: 94ZLA3W45F
Adrenal and DHEAARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA.ProBLEN44991952-c440-4a33-9423-a9369c8bab702021-10-22WarningsExact identifier
unii: 94ZLA3W45F
AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTANMylan Pharmaceuticals Inc.aa7e7d95-520a-461c-b1b3-e588aeb6a6132021-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LPc2c51ec3-ffb0-4240-b048-a8e424775a762021-08-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: L11K75P92J
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCafcffa7b-03b7-499a-b50c-37b0e28c77372021-05-11Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
CLINIMIX ELEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSEBaxter Healthcare Company8469d6fb-d6ef-476f-8cc3-0905192de0a82021-04-13Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F
CLINIMIXLEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSEBaxter Healthcare Corporationdccff103-8695-400c-a15d-cc2fd078760a2021-04-13Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILGlenmark Pharmaceuticals Inc., USA2edf43fb-0755-4ffb-bc38-75a4e24325882021-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylate and Atorvastatin calciumAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMDr. Reddy's Laboratories Incabee4a34-89cc-d886-192c-32582ab8f0242021-02-16Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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