FDA.reportPublic FDA data

Opium

Product NDC
64950-258
Requested package NDC
64950-258-11
11-digit product format
649500258
Labeler code
64950
Product ID
64950-258_b937d1d0-9ed8-4aa3-9e4a-cce02870e7e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine
Dosage form
TINCTURE
Route
ORAL
Labeler
Genus Lifesciences Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-05-15
Substance
MORPHINE
Active strength
1 g/100mL
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

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
76I7G6D29CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830196Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a77894b-2137-4f46-8dff-5c7b773d4d16Available on FDA.report

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
64950-258-11Opium118 mL in 1 BOTTLETINCTURE1181

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OpiumMORPHINEGenus Lifesciences Inc.8a77894b-2137-4f46-8dff-5c7b773d4d162026-05-07Warnings, Adverse reactionsExact identifier
ndc (package): 64950-258-11
ndc (product): 64950-258
ndc11 (package): 64950025811

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830196opium tincture 10 MG (as morphine equivalent) in 1 mL Oral SolutionPSN8a77894b-2137-4f46-8dff-5c7b773d4d161
830196opium tincture 100 MG/ML Oral SolutionSCD8a77894b-2137-4f46-8dff-5c7b773d4d161
830196anhydrous morphine 1 % Oral SolutionSY8a77894b-2137-4f46-8dff-5c7b773d4d161
830196anhydrous morphine 10 MG/ML Oral SolutionSY8a77894b-2137-4f46-8dff-5c7b773d4d161
830196opium tincture 10 % Oral SolutionSY8a77894b-2137-4f46-8dff-5c7b773d4d161
830196opium tincture 10 MG (as morphine equivalent) per 1 ML Oral SolutionSY8a77894b-2137-4f46-8dff-5c7b773d4d161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64950-258-1164950025811118 mL in 1 BOTTLE (64950-258-11) 118 ml2026-05-15NoNoCurrent