FDA.reportPublic FDA data

NDC 51079-745-01 - 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
51079-745
Requested NDC
51079-745-01
Package NDCs from labels
51079-745-01, 51079-745-20
Manufacturer
Mylan Institutional Inc.
Effective date
2019-09-27
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.2019-09-27HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-745-01EA - Each51079-74528e81654-12df-41e1-a577-0d286ce294d712012-07-24
51079-745-17EA - Each51079-745b9ba942d-7978-4562-a9a3-c6dedd6b9f2012012-07-24
51079-745-19EA - Each51079-7456ddd734a-d88c-4a6d-843c-240f2c02c8ed12012-07-24
51079-745-20EA - Each51079-745756bb48f-d034-4c7f-bf5c-a154e080740312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4

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 8 · 155 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
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESafecor Health LLCfc02db0f-5311-4b61-896e-bfe3408327352026-08-20Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHF Acquisition Co. LLC DBA HealthFirst59464700-f7f1-6ab0-e063-6394a90aa7782026-08-17Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
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
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackec928ee5-0809-4ba5-82ca-ecfed99ebb5a2026-07-21Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
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
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEAmerican Health Packaging11b43a17-8038-462b-8902-259431ad52562026-06-22Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions465dbab3-f201-4441-8f55-92a843b5134f2026-06-19Warnings, Adverse reactionsExact identifier
unii: OLH94387TE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEGolden State Medical Supply, Inc.c9f17187-e958-106b-e053-2a95a90a54d82026-06-16Warnings, Adverse reactionsExact identifier
unii: OLH94387TE

Reported adverse events (FAERS/openFDA)#

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