Morphine Sulfate

Product NDC
0409-3815
11-digit product format
004093815
Labeler code
0409
Product ID
0409-3815_0a2ba20b-448f-4412-9899-b82040ebfa7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INTRATHECAL; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA073510
Marketing category
ANDA
Marketing start
2005-06-29
Substance
MORPHINE SULFATE
Active strength
1 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Morphine Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui1728783, 1728800

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
944b0689-73f4-6a2f-c654-1180896353c0Product name420220210
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
67e166c6-23d4-4709-b77d-5ca6182dcae0Product name120180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c573a64c-fe17-2eac-fbcb-788868b4ff6bProduct name920180619
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
7c1819cf-69a0-41dc-aeaa-a820729bc959Product name120170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2eProduct name520161114
175682a8-c657-45a2-9dfb-c565306b03c8Product name120160112
b73dadd0-1b4a-4f88-956f-a2be216c8fadProduct name120151123
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4c272b1c-87fc-ebc0-994d-ac28b1e0416eProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3815-11Morphine Sulfate10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1029
0409-3815-12Morphine Sulfate5 in 1 CARTONINJECTION, SOLUTION529

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3815-11ML - Milliliter0409-3815effd4c02-8b78-456e-96e1-2108612cb17212019-07-02
0409-3815-12ML - Milliliter0409-3815d04e1a7b-3f57-4b83-b905-35fdff2e107712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]11
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]11
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]11
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3815MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]26Current NDC, Legacy NDC, 2 package rows20241208_1d181906-f3ec-4222-1883-e61577a3122e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728800morphine sulfate 10 MG in 10 ML InjectionPSN1d181906-f3ec-4222-1883-e61577a3122e29
1728783morphine sulfate 5 MG in 10 ML InjectionPSN1d181906-f3ec-4222-1883-e61577a3122e29
172878310 ML morphine sulfate 0.5 MG/ML InjectionSCD1d181906-f3ec-4222-1883-e61577a3122e29
172880010 ML morphine sulfate 1 MG/ML InjectionSCD1d181906-f3ec-4222-1883-e61577a3122e29
172878310 ML MS 0.5 MG/ML InjectionSY1d181906-f3ec-4222-1883-e61577a3122e29
172880010 ML MS 1 MG/ML InjectionSY1d181906-f3ec-4222-1883-e61577a3122e29
1728800morphine sulfate 10 MG per 10 ML InjectionSY1d181906-f3ec-4222-1883-e61577a3122e29
1728783morphine sulfate 5 MG per 10 ML InjectionSY1d181906-f3ec-4222-1883-e61577a3122e29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3815-110040938151110 mL in 1 VIAL, GLASS10 mlHistorical
0409-3815-12004093815125 VIAL, GLASS in 1 CARTON (0409-3815-12) / 10 mL in 1 VIAL, GLASS (0409-3815-11) 2005-06-290000-00-00NoNoCurrent