FDA.reportPublic FDA data

NDC 0409-4350-13 - 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
0409-4350
Requested NDC
0409-4350-13
Package NDCs from labels
0409-4350-13, 0409-4350-03
Manufacturer
Hospira, Inc.
Effective date
2026-05-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DILTIAZEM HYDROCHLORIDE INJECTIONHospira, Inc.2026-05-24HUMAN PRESCRIPTION DRUG LABEL
DILTIAZEM HCI - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-03-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4350-03Diltiazem Hydrochloride10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,1021
0409-4350-13Diltiazem Hydrochloride1 in 1 VIAL, PATENT DELIVERY SYSTEMINJECTION, POWDER, LYOPHILIZED,121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4350DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION DILTIAZEM HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]20Current NDC, Legacy NDC, 2 package rows20230118_bba03666-ff4f-4bf6-fa92-78e1ec2d9073.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4350-03EA - Each0409-4350fa114bcc-ee51-4aea-9b61-1495bf75952512012-07-24
0409-4350-13EA - Each0409-43502aff4ff2-1d62-443b-aad3-0200cad4c5a512019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
SORBITOLINACTIVE INGREDIENT506T60A25RDILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
WATERINACTIVE INGREDIENT059QF0KO0RDILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10

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 1 of 21 · 416 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEGolden State Medical Supply, Inc.5a0f67ad-17d8-a3f4-e063-6394a90afb322026-08-27Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESafecor Health LLCfc02db0f-5311-4b61-896e-bfe3408327352026-08-20Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHF Acquisition Co. LLC DBA HealthFirst59464700-f7f1-6ab0-e063-6394a90aa7782026-08-17Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
CVS Health Nausea ReliefSODIUM CITRATE DIHYDRATECVS PHARMACY,INC.a5f9de6f-70d8-4bb0-8a5b-3dd120df29902026-08-14WarningsExact identifier
unii: B22547B95K
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TIAZAC EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBausch Health US, LLCc567fe7e-887e-4291-a0d1-2dd3f25cbf252026-08-07Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESagent Pharmaceuticals9d51c0f6-26b7-4220-83fb-4e736b289e642026-08-06Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDENORTHSTAR RX LLC56616fc9-f3f7-8e0a-22c8-a6af106e6b1d2026-08-05Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESlate Run Pharmaceuticals, LLCf7137458-0db3-7ecd-e053-6394a90a5f952026-08-05Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESlate Run Pharmaceuticals, LLCe66665e8-22eb-f5cd-e053-2a95a90a72e42026-08-05Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackec928ee5-0809-4ba5-82ca-ecfed99ebb5a2026-07-21Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMajor Pharmaceuticalse7476adc-a940-4e76-a1dd-c418de493bc02026-07-14Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackfb6a6199-bb70-476e-a2a2-b7594c9c001a2026-07-10Warnings, Adverse reactionsExact identifier
unii: OLH94387TE

Reported adverse events (FAERS/openFDA)#

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