FDA.reportPublic FDA data

NDC 51079-926-01 - 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
51079-926
Requested NDC
51079-926-01
Package NDCs from labels
51079-926-01, 51079-926-20
Manufacturer
Mylan Institutional Inc.
Effective date
2025-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diltiazem Hydrochloride - Mylan Institutional Inc.Mylan Institutional Inc.2025-07-18HUMAN 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
51079-926-01Diltiazem Hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE110
51079-926-20Diltiazem Hydrochloride100 in 1 CARTONCAPSULE, EXTENDED RELEASE10010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-926DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]9Current NDC, Legacy NDC, 2 package rows20230404_9942f1a2-f66d-4d9e-9794-49bee8abf5ab.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-926-01EA - Each51079-926ac34f111-b0a7-4f5c-b450-6c958fd93d0a12012-07-24
51079-926-20EA - Each51079-9263a68b764-3697-4f07-a491-92bda6c7d73112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2

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 149 · 2,970 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEGolden State Medical Supply, Inc.5a0f67ad-17d8-a3f4-e063-6394a90afb322026-08-27Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESafecor Health LLCfc02db0f-5311-4b61-896e-bfe3408327352026-08-20Warnings, Adverse reactionsExact identifier
application number: ANDA074910
rxcui: 830872
rxcui: 830865
rxcui: 830869
unii: OLH94387TE

Reported adverse events (FAERS/openFDA)#

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