FDA.reportPublic FDA data

NDC 0641-6014-01 - Diltiazem Hydrochloride

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
0641-6014
Requested NDC
0641-6014-01
Package NDCs from labels
0641-6014-01, 0641-6014-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diltiazem Hydrochloride Injection Rx OnlyHikma Pharmaceuticals USA Inc.2024-04-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6014-01Diltiazem Hydrochloride10 mL in 1 VIALINJECTION105
0641-6014-10Diltiazem Hydrochloride10 in 1 CARTONINJECTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6014DILTIAZEM HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240410_453b73bd-c52d-4d72-a0b3-47588e723e0b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6014-01ML - Milliliter0641-6014ca46bccc-cb32-4db4-8a74-e9df3e094fea12012-07-24
0641-6014-10ML - Milliliter0641-6014a2385cab-109e-4588-9bdc-989af5b5daf212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

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 10 of 22 · 440 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EndocrinpathALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corporation70f84941-b8a1-48f4-9c05-554e554f00492025-07-11WarningsExact identifier
unii: XF417D3PSL
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEBelleview Biosciences LLC3245e0e5-5e7f-c3f7-e063-6394a90ac2582025-07-07Adverse reactionsExact identifier
unii: 1Q73Q2JULR
unii: XF417D3PSL
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
unii: 506T60A25R
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEIngenus Pharmaceuticals, LLC355f560a-8ebb-4661-ad74-2a22f707d7f82025-06-17Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
TIADYLT ERDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackb4b4e53e-fc99-4f34-abc2-57e4f28aff842025-06-13Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc044f774-783f-4920-a8a1-6d4b1b3820c12025-06-11Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Cartia XTDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackde671934-25a8-4df6-b7a1-97e0337e9e2b2025-06-02Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDETeva Pharmaceuticals USA, Inc.69ca7cae-fdf3-413a-900b-95cf6e9e7b632025-05-30Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 1Q73Q2JULR
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDESun Pharmaceutical Industries, Inc.976d9dd0-4f11-4439-b84e-0c0f0e018d8b2025-05-22Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEViona Pharmaceuticals Inc43cffe12-304a-4e15-9512-94f812188f1a2025-05-05Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
TIADYLT ERDILTIAZEM HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.1278cd76-b8e9-42d9-ad19-6858e72cf9f22025-05-02Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
TIADYLT ERDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limitedd88e3546-3984-4dc9-893a-a29e958045502025-05-02Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECoupler LLC3418eb02-117e-a71a-e063-6394a90a826e2025-05-01Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.1e2f2025-0350-40c4-ab42-3b57f3d105a62025-05-01Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEActavis Pharma, Inc.178eec1f-1d4d-4a38-b66a-d3ba3de06c3d2025-05-01Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limitedfe790439-85d4-4cd8-a385-149ea3442a382025-05-01Warnings, Adverse reactionsExact identifier
unii: OLH94387TE

Reported adverse events (FAERS/openFDA)#

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