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 9 of 22 · 440 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc8809dc9-b99b-4d30-a7da-0bc21aa90f9c2025-10-02Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEProPharma Distribution3f2942d7-f4d0-2d77-e063-6294a90a74ad2025-09-18Warnings, Adverse reactionsExact identifier
rxcui: 1791229
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc1ef9e90-6ff0-4ee5-86a3-1efee9c367892025-09-16Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Inc.ac9aa10d-cd52-4ac9-a01d-e3cbf14d49132025-08-30Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacke6d9397c-f8a2-42d6-88ca-55060b1d073a2025-08-26Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack9041cc05-29d2-41ca-a368-e953bf3443b52025-08-25Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack0089fc7a-a7aa-4873-b699-39a1b21616ca2025-08-20Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECipla USA, Inc.bce61158-201d-458c-be0c-9bdd2d3a0bec2025-08-01Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEOCEANSIDE PHARMACEUTICALS43892b97-449d-45bc-bb09-29d47c655d652025-07-31Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMylan Institutional Inc.9942f1a2-f66d-4d9e-9794-49bee8abf5ab2025-07-18Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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