FDA.reportPublic FDA data

NDC 0591-0760 - Ranitidine 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
0591-0760
Package NDCs from labels
0591-0760-60, 0591-0760-05
Manufacturer
Watson Laboratories, Inc.
Effective date
2006-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
70012980 Ranitidine Tablets USP Revised: June 2005 Rx onlyWatson Laboratories, Inc.2006-12-18HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0760-05Ranitidine Hydrochloride500 in 1 BOTTLETABLET5002
0591-0760-60Ranitidine Hydrochloride60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0760RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]22 package rows20070119_A699614A-8E5B-4BEC-81C9-49305129EB39.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ranitidine HydrochlorideACTIVE INGREDIENTBK76465IHMRANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
RanitidineACTIVE MOIETY884KT10YB7RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
Colloidal silicon dioxideINACTIVE INGREDIENTRANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
HypromelloseINACTIVE INGREDIENTRANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
Magnesium stearateINACTIVE INGREDIENT70097M6I30RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
MaltodextrinINACTIVE INGREDIENTRANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
Microcrystalline celluloseINACTIVE INGREDIENTRANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
PolydextroseINACTIVE INGREDIENTRANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
Polyethylene glycolINACTIVE INGREDIENTRANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
Sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QORANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
Synthetic red iron oxideINACTIVE INGREDIENTRANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
Synthetic yellow iron oxideINACTIVE INGREDIENTRANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
TalcINACTIVE INGREDIENT7SEV7J4R1URANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]2
Triethyl citrateINACTIVE INGREDIENTRANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) TABLET [WATSON LABORATORIES, 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 1 ยท 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RanitidineRANITIDINEAmneal Pharmaceuticals of New York LLCb38a3332-5c54-453f-aeb7-070f830955c22026-05-01Adverse reactionsExact identifier
rxcui: 198193
rxcui: 198191
RANITIDINERANITIDINERising Pharma Holdings, Inc.0fba6615-37c2-4ba6-b6e5-09599369a5bc2025-12-05Adverse reactionsExact identifier
rxcui: 198193
rxcui: 198191
RanitidineRANITIDINEDr. Reddy's Laboratories Limited00df8a42-296f-80dd-98af-ee8b30eb38cc2025-05-23WarningsExact identifier
rxcui: 198191
5372428D-E69B-F80E-A538-94355F9F28E3A699614A-8E5B-4BEC-81C9-49305129EB392006-12-18Adverse reactionsExact identifier
spl id: 5372428D-E69B-F80E-A538-94355F9F28E3
spl set id: A699614A-8E5B-4BEC-81C9-49305129EB39

Reported adverse events (FAERS/openFDA)#

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