FDA.reportPublic FDA data

NDC 0641-6013-01 - 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
0641-6013
Requested NDC
0641-6013-01
Package NDCs from labels
0641-6013-01, 0641-6013-10
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
Diltiazem Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-30HUMAN PRESCRIPTION DRUG LABEL
DILTIAZEM HCI - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2023-01-19HUMAN 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
0641-6013-01Diltiazem Hydrochloride5 mL in 1 VIALINJECTION55
0641-6013-10Diltiazem Hydrochloride10 in 1 CARTONINJECTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6013DILTIAZEM 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
0641-6013-01ML - Milliliter0641-6013bd46813c-ccbc-429a-8129-b69249207df812012-07-24
0641-6013-10ML - Milliliter0641-60135a1e1049-8d91-4e79-a05b-758a1fbe9a1a12012-07-24

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 5 of 22 · 440 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacka469b24a-fbec-4a2d-8b4c-b62c2b2c66f62026-02-17Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHikma Pharmaceuticals USA Inc.734beeef-3968-4137-af2c-276e8a9317df2026-02-09Warnings, Adverse reactionsExact identifier
application number: ANDA078538
rxcui: 1791232
rxcui: 1791229
rxcui: 1791233
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutionse99e1446-9c85-478c-9e23-a5f4104bbd222026-02-06Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEGLENMARK PHARMACEUTICALS INC., USAfb1606ea-1cff-46fd-b8e5-8135da76436c2026-01-29Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: 1Q73Q2JULR
unii: XF417D3PSL
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Cell Energy Performance Drops 2048CELL ENERGY PERFORMANCE DROPSProfessional Complementary Health Formulas8701ea61-5d5f-466b-8d2c-f808e7b4d8fe2026-01-08WarningsExact identifier
unii: XF417D3PSL
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: XF417D3PSL
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: XF417D3PSL
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENorthwind Health Company, LLC106b33e3-b199-e555-e063-6294a90a5af52026-01-01Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENorthwind Health Company, LLC09a5d332-347b-e73d-e063-6294a90a67ed2026-01-01Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENorthwind Health Company, LLCf29febd6-5a27-eb83-e053-2a95a90a5b7d2026-01-01Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
unii: 506T60A25R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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