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 12 of 22 · 440 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARTIA XTDILTIAZEM HYDROCHLORIDEDirectRxdbfda3a5-5602-6e47-e053-2995a90ac07b2025-01-22Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HCL ERDILTIAZEM HCL ERDirect_Rxf1ea85b2-ecd2-5867-e053-2a95a90a24dc2025-01-22Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 1Q73Q2JULR
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc7c6a74e-5f73-4265-a0e0-8fd2cd26909e2025-01-21Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
DILTIAZEM HYDROCHLORIDE EXTENDED RELEASEDILTIAZEM HYDROCHLORIDE EXTENDED RELEASEdirect rxc7cf9276-4b4c-10b2-e053-2995a90a37382025-01-20Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: 1Q73Q2JULR
unii: XF417D3PSL
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 506T60A25R
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Limitedd9c5c1ed-1a9d-494c-b798-9da09ba1fe1b2024-12-26Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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