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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-910-30	Hypertenipine	30 in 1 BOTTLE	TABLET	30	2.5 mg	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-910	HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7	Unmatched	20110812_2fcc87a4-74ef-46bd-8ee9-bd2f3cf3d0c2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
ARGININE	ACTIVE INGREDIENT	94ZLA3W45F	HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
AMLODIPINE	ACTIVE MOIETY	1J444QC288	HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
ARGININE	ACTIVE MOIETY	94ZLA3W45F	HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	HYPERTENIPINE (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 15 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOTAL PRO-JES	ADRENAL,BELLADONNA,CHELIDONIUM,DIOSCOREAVILLOSA,FOLLICULINUM,HYPOTHALAMUS,ARGININE,LILIUMTIGRINIUM,LIVER,OOPHORINUM,PINEAL,PITUITARINUM,PLACENTANIUM,PROGESTERONE	White Manufacturing Inc. BDA Micro-West	b26953f8-7b56-432c-958c-d80c528fbb6a	2021-01-21	Warnings	Exact identifier unii: 94ZLA3W45F
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	Teva Pharmaceuticals USA, Inc.	5c128ef2-60a6-40f3-b37f-ee139fe27987	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 864V2Q084H
MEDULLOSSEINUM PLEX	ARNICA MONTANA, CALCAREA PHOSPHORICA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, MEDULLOSSEINUM, PULSATILLA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE	Seroyal USA	22b7eafe-ef76-0677-e054-00144ff88e88	2020-10-09	Warnings	Exact identifier unii: L11K75P92J
Travasol	LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE	Baxter Healthcare Corporation	8543b5be-0f43-4891-9e56-d7c39fe839b5	2020-10-07	Warnings, Adverse reactions	Exact identifier unii: 94ZLA3W45F
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	9f327d08-7661-4088-b554-2f9a99a113e7	2020-10-01	Warnings, Adverse reactions	Exact identifier unii: 864V2Q084H
Amlodipine Besylate	AMLODIPINE BESYLATE	Cipla USA Inc.	0c8d6b2f-3e4a-47a2-80e2-a34dcb337555	2020-09-09	Warnings, Adverse reactions	Exact identifier application number: ANDA077955 rxcui: 308136 unii: 864V2Q084H
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Proficient Rx LP	410aa0a5-43cf-455c-b51d-7dfbc24eee32	2020-02-01	Warnings, Adverse reactions	Exact identifier unii: 864V2Q084H
Norvasc	AMLODIPINE BESYLATE	PFIZER LABORATORIES DIV PFIZER INC	abd6a2ca-40c2-485c-bc53-db1c652505ed	2019-01-15	Warnings, Adverse reactions	Exact identifier rxcui: 308136 unii: 864V2Q084H
Telmisartan and Amlodipine	TELMISARTAN AND AMLODIPINE	Mylan Pharmaceuticals Inc.	ca60a4d5-ace7-4889-94ee-e2265fd63811	2018-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 864V2Q084H
Amlodipine besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	17e6d552-7528-4597-9498-104cb04f32e7	2017-10-25	Warnings, Adverse reactions	Exact identifier application number: ANDA077955 unii: 864V2Q084H
d53898b9-1426-4954-a7f3-945918a4e46a			2fcc87a4-74ef-46bd-8ee9-bd2f3cf3d0c2	2011-08-01	Warnings, Adverse reactions	Exact identifier spl id: d53898b9-1426-4954-a7f3-945918a4e46a spl set id: 2fcc87a4-74ef-46bd-8ee9-bd2f3cf3d0c2

Reported adverse events (FAERS/openFDA)#

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