FDA.reportPublic FDA data

NDC 0591-0617-05 - Morphine Sulfate

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
0591-0617
Requested NDC
0591-0617-05
Package NDCs from labels
0591-0617-01, 0591-0617-05
Manufacturer
Watson Laboratories, Inc.
Effective date
2006-04-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Morphine Sulfate Extended-Release Tablets C-II Rx only 30340-2Watson Laboratories, Inc.2006-04-12HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0617-01Morphine Sulfate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001
0591-0617-05Morphine Sulfate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0617MORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]12 package rows20060828_A2C1F1B7-70B0-416B-8BDF-9EAED156E34B.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Morphine SulfateACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
MorphineACTIVE MOIETY76I7G6D29CMORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
cetostearyl alcoholINACTIVE INGREDIENTMORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
hydroxyethyl celluloseINACTIVE INGREDIENTMORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
hydroxypropyl celluloseINACTIVE INGREDIENTMORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
hypromelloseINACTIVE INGREDIENTMORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
polyethylene glycolINACTIVE INGREDIENTMORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
polysorbate 80INACTIVE INGREDIENTMORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
synthetic black iron oxideINACTIVE INGREDIENTMORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]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 1 of 1 ยท 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MORPHINE SULFATEMORPHINE SULFATESpecGx LLC533034fd-c8e7-495b-8874-0db41bd1e65a2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 891874
Morphine Sulfate Extended ReleaseMORPHINE SULFATEMajor Pharmaceuticalsdbb37dfd-0196-45f7-b9ca-393f56cf1d282026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 891874
Morphine Sulfate Extended ReleaseMORPHINE SULFATERhodes Pharmaceuticals LLC19c7d9cc-6ce2-4c5c-8c3f-c24fd33428042026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 891874
Morphine sulfateMORPHINE SULFATESun Pharmaceutical Industries, Inc.736c9b80-682c-4cda-bf18-61b18de0bd392026-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 891874
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack07993f6c-146b-4728-a2da-6e93089f78ff2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 891874
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack3a89d0ca-4ff8-4bdc-8ea8-9ad591ce72262026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 891874
Morphine SulfateMORPHINE SULFATELupin Pharmaceuticals,Inc.d360a33f-6323-4b10-9e81-07e2813c2dbd2024-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 891874
A2C1F1B7-70B0-416B-8BDF-9EAED156E34BA2C1F1B7-70B0-416B-8BDF-9EAED156E34B2006-04-12Warnings, Adverse reactionsExact identifier
spl id: A2C1F1B7-70B0-416B-8BDF-9EAED156E34B
spl set id: A2C1F1B7-70B0-416B-8BDF-9EAED156E34B

Reported adverse events (FAERS/openFDA)#

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