FDA.reportPublic FDA data

Opium Tincture Deodorized

Product NDC
62559-153
Requested package NDC
62559-153-04
11-digit product format
625590153
Labeler code
62559
Product ID
62559-153_947837c2-ec58-479d-9752-50820f34af6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine tincture
Dosage form
SOLUTION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-25
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
2026-12-31
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 Tincture Deodorized
Listing expiration
2026-12-31

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
674a969a-707d-41a9-b7c3-b90cbf2909e3Available 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
62559-153-04Opium Tincture Deodorized118 mL in 1 BOTTLESOLUTION1185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-153-04ML - Milliliter62559-153a47b13b5-78ef-4db8-93a4-5f89b76ca4d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINEACTIVE INGREDIENT76I7G6D29COPIUM TINCTURE DEODORIZED (MORPHINE TINCTURE) SOLUTION [ANI PHARMACEUTICALS, INC.]2
MORPHINEACTIVE MOIETY76I7G6D29COPIUM TINCTURE DEODORIZED (MORPHINE TINCTURE) SOLUTION [ANI PHARMACEUTICALS, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MOPIUM TINCTURE DEODORIZED (MORPHINE TINCTURE) SOLUTION [ANI PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0ROPIUM TINCTURE DEODORIZED (MORPHINE TINCTURE) SOLUTION [ANI PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-153OPIUM TINCTURE DEODORIZED (MORPHINE TINCTURE) SOLUTION [ANI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20181204_674a969a-707d-41a9-b7c3-b90cbf2909e3.zip

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
Opium Tincture DeodorizedMORPHINE TINCTUREANI Pharmaceuticals, Inc.674a969a-707d-41a9-b7c3-b90cbf2909e32025-09-08Warnings, Adverse reactionsExact identifier
ndc (package): 62559-153-04
ndc (product): 62559-153
ndc11 (package): 62559015304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830196opium tincture 10 MG (as morphine equivalent) in 1 mL Oral SolutionPSN5c1ddfd9-b0be-4e7f-a48c-68f8dc96e672103
830196opium tincture 100 MG/ML Oral SolutionSCD5c1ddfd9-b0be-4e7f-a48c-68f8dc96e672103
830196anhydrous morphine 1 % Oral SolutionSY5c1ddfd9-b0be-4e7f-a48c-68f8dc96e672103
830196anhydrous morphine 10 MG/ML Oral SolutionSY5c1ddfd9-b0be-4e7f-a48c-68f8dc96e672103
830196opium tincture 10 % Oral SolutionSY5c1ddfd9-b0be-4e7f-a48c-68f8dc96e672103
830196opium tincture 10 MG (as morphine equivalent) per 1 ML Oral SolutionSY5c1ddfd9-b0be-4e7f-a48c-68f8dc96e672103
830196opium tincture 10 MG (as morphine equivalent) in 1 mL Oral SolutionPSN674a969a-707d-41a9-b7c3-b90cbf2909e35
830196opium tincture 100 MG/ML Oral SolutionSCD674a969a-707d-41a9-b7c3-b90cbf2909e35
830196anhydrous morphine 1 % Oral SolutionSY674a969a-707d-41a9-b7c3-b90cbf2909e35
830196anhydrous morphine 10 MG/ML Oral SolutionSY674a969a-707d-41a9-b7c3-b90cbf2909e35
830196opium tincture 10 % Oral SolutionSY674a969a-707d-41a9-b7c3-b90cbf2909e35
830196opium tincture 10 MG (as morphine equivalent) per 1 ML Oral SolutionSY674a969a-707d-41a9-b7c3-b90cbf2909e35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-153-0462559015304118 mL in 1 BOTTLE (62559-153-04) 118 ml2011-02-250000-00-00NoNoCurrent