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 12 of 15 · 288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATEAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCd17ef907-7719-4246-8ade-b67afdfaf7872024-03-26Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.ffe96aa1-db66-33e4-e053-6394a90a7e4e2024-03-26Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILAmneal Pharmaceuticals NY LLC02f9b562-6f7f-4783-bb0d-67c318073e1c2024-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Dr Dale Wellness NU Fem 1 2 3 All In One Topical HomeopathicDHEA,ADRENAL CORTISOL,GLANDULA SUPRARENALIS SUIS,HUMAN GROWTH HORMONE,IGF-I,IGF-II ,HYPOTHALAMUS,PITUITARY,PLACENTA,LIVER,THYMUS,RNA,DNA,ESTROGENIUM,ESTRADIOLINUM,SANGUINARA CANDENSIS,OOPHORINUM,PROGESTERONIUM,PITITUARINUM,PINEAL,FOLLICULINUM,OVARINUM,CHELADONIUM,SULPHUR,SEPIA,LAGENINE ,TESTOSTERONE,CIMICIFUGA BLACK COHOSH,LILIUM TIGRINUM,GRAPHITES,KALI PHOSPHORICUM ,CAUSTICUM,CALCAREA CARBONICA,PHYTOLACCA,SCROPHULARIA NODOSADMD Clinical Naturopathy7679472c-bc6a-40c1-8e66-adc0b6ca18b42024-03-21WarningsExact identifier
unii: 94ZLA3W45F
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC132c078d-7d31-a6f2-e063-6294a90af0952024-03-08Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack52daa759-3327-461a-8cfc-3c6253df91ec2024-03-05Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATETeva Pharmaceuticals, Inc.47edc328-2444-4ca1-a5c1-7c83141e105c2024-03-01Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepackb404a550-0df4-404a-8d10-c35e197ca3992024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack44dc874b-4377-46eb-ae32-8d84c9c4d4ae2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepack498a9b21-34b9-4373-930b-5ed43201a3452024-01-09Warnings, Adverse reactionsExact identifier
application number: ANDA077955
rxcui: 308136
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepacke8958997-f098-44ce-8c21-b7064d1a962e2024-01-09Warnings, Adverse reactionsExact identifier
application number: ANDA077955
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions55bfd9ea-b474-4863-8fae-1b720d91034c2024-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINELupin Pharmaceuticals, Inc.a97fefa6-99e6-4eb7-9393-ab2252a2c7d82023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe2023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and ValsartanAMLODIPINE AND VALSARTANLupin Pharmaceuticals, Inc.35086164-bf92-4b3c-9845-f8cd7464c7d62023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack900024f4-23d6-4505-81db-4f643e12858c2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions5c50c3fe-afe5-459e-95c0-c9af4cbb69092023-11-13Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions89d8d490-3a9c-40f2-86b7-94b5101dd09a2023-10-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 94ZLA3W45F
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions4512feee-a09d-4244-bc03-c43193e53a0e2023-09-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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