FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0054-0236
11-digit product format
000540236
Labeler code
0054
Product ID
0054-0236_c89c4f71-eab3-4b74-b098-fcd31d5aa0dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA022207
Marketing category
NDA
Marketing start
2008-03-17
Substance
MORPHINE SULFATE
Active strength
30 mg/1
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 SULFATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui892582, 892672

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
944b0689-73f4-6a2f-c654-1180896353c0Product name420220210
67e166c6-23d4-4709-b77d-5ca6182dcae0Product name120180830
c573a64c-fe17-2eac-fbcb-788868b4ff6bProduct name920180619
7c1819cf-69a0-41dc-aeaa-a820729bc959Product name120170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2eProduct name520161114
175682a8-c657-45a2-9dfb-c565306b03c8Product name120160112
b73dadd0-1b4a-4f88-956f-a2be216c8fadProduct name120151123
4c272b1c-87fc-ebc0-994d-ac28b1e0416eProduct name120140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0236-24Morphine Sulfate100 in 1 CARTONTABLET10013
0054-0236-24Morphine Sulfate1 in 1 BLISTER PACKTABLET113
0054-0236-25Morphine Sulfate100 in 1 BOTTLETABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0236-24EA - Each0054-0236c034221d-9ec7-4fef-9442-16d6b04c31c412012-07-24
0054-0236-25EA - Each0054-0236f0faba78-9882-46d6-a2a8-ed123493d4bb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]7
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]7
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC]4
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC]4
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET [STAT RX USA LLC]2
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET [H.J. HARKINS COMPANY, INC.]2
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET [STAT RX USA LLC]2
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMORPHINE SULFATE TABLET [STAT RX USA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MORPHINE SULFATE TABLET [STAT RX USA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMORPHINE SULFATE TABLET [STAT RX USA LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMORPHINE SULFATE TABLET [STAT RX USA LLC]2
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0236MORPHINE SULFATE TABLET [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 3 package rows20231219_3c847554-3b4b-4d24-a145-2ef7e9b83699.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892582morphine sulfate 15 MG Oral TabletPSN3c847554-3b4b-4d24-a145-2ef7e9b8369913
892672morphine sulfate 30 MG Oral TabletPSN3c847554-3b4b-4d24-a145-2ef7e9b8369913
892582morphine sulfate 15 MG Oral TabletSCD3c847554-3b4b-4d24-a145-2ef7e9b8369913
892672morphine sulfate 30 MG Oral TabletSCD3c847554-3b4b-4d24-a145-2ef7e9b8369913
892582MS 15 MG Oral TabletSY3c847554-3b4b-4d24-a145-2ef7e9b8369913
892672MS 30 MG Oral TabletSY3c847554-3b4b-4d24-a145-2ef7e9b8369913
892582morphine sulfate 15 MG Oral TabletPSN680a996c-08a5-4cdb-b7bd-0ada5d8c7adf7
892672morphine sulfate 30 MG Oral TabletPSN680a996c-08a5-4cdb-b7bd-0ada5d8c7adf7
892582morphine sulfate 15 MG Oral TabletSCD680a996c-08a5-4cdb-b7bd-0ada5d8c7adf7
892672morphine sulfate 30 MG Oral TabletSCD680a996c-08a5-4cdb-b7bd-0ada5d8c7adf7
892582MS 15 MG Oral TabletSY680a996c-08a5-4cdb-b7bd-0ada5d8c7adf7
892672MS 30 MG Oral TabletSY680a996c-08a5-4cdb-b7bd-0ada5d8c7adf7
892582morphine sulfate 15 MG Oral TabletPSNd4286d3c-7226-47a6-9fbc-e67e60e462862
892582morphine sulfate 15 MG Oral TabletPSNca2e2b04-c12c-4957-a93e-f8bbe554a8be2
892672morphine sulfate 30 MG Oral TabletPSNca2e2b04-c12c-4957-a93e-f8bbe554a8be2
892672morphine sulfate 30 MG Oral TabletPSNd4286d3c-7226-47a6-9fbc-e67e60e462862
892582morphine sulfate 15 MG Oral TabletSCDd4286d3c-7226-47a6-9fbc-e67e60e462862
892582morphine sulfate 15 MG Oral TabletSCDca2e2b04-c12c-4957-a93e-f8bbe554a8be2
892672morphine sulfate 30 MG Oral TabletSCDca2e2b04-c12c-4957-a93e-f8bbe554a8be2
892672morphine sulfate 30 MG Oral TabletSCDd4286d3c-7226-47a6-9fbc-e67e60e462862
892582MS 15 MG Oral TabletSYca2e2b04-c12c-4957-a93e-f8bbe554a8be2
892582MS 15 MG Oral TabletSYd4286d3c-7226-47a6-9fbc-e67e60e462862
892672MS 30 MG Oral TabletSYca2e2b04-c12c-4957-a93e-f8bbe554a8be2
892672MS 30 MG Oral TabletSYd4286d3c-7226-47a6-9fbc-e67e60e462862
892672morphine sulfate 30 MG Oral TabletPSN67b3273e-af71-4dac-8e49-8bc134d4c5911
892672morphine sulfate 30 MG Oral TabletSCD67b3273e-af71-4dac-8e49-8bc134d4c5911
892672MS 30 MG Oral TabletSY67b3273e-af71-4dac-8e49-8bc134d4c5911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0236-2400054023624100 BLISTER PACK in 1 CARTON (0054-0236-24) / 1 TABLET in 1 BLISTER PACK100 blister pack2008-03-170000-00-00NoNoCurrent
0054-0236-2500054023625100 TABLET in 1 BOTTLE (0054-0236-25) 100 tablet2008-03-170000-00-00NoNoCurrent