FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0409-1134
Requested package NDC
0409-1134-05
11-digit product format
004091134
Labeler code
0409
Product ID
0409-1134_a641ae70-f6ba-4f49-b5fc-b2895ef3408f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2005-08-11
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
50 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0409-11340409-1134-05DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1134-03ML - Milliliter0409-11348ad5691c-da5d-46cd-b9db-2e6f68b9653112013-02-13
0409-1134-05ML - Milliliter0409-1134c2b10f10-9769-4058-b725-3971b797fc0212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMORPHINE SULFATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CMORPHINE SULFATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFMORPHINE SULFATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1134MORPHINE SULFATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]7Legacy NDC20211019_cadc3fdb-8edc-44cd-aaea-89e68aaf9a04.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-1134-05004091134051 VIAL, SINGLE-DOSE in 1 CARTON (0409-1134-05) > 50 mL in 1 VIAL, SINGLE-DOSE2005-08-110000-00-00NoNoCurrent