FDA.reportPublic FDA data

Opium Tincture Deodorized

Product NDC
62559-153
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

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 Identifiers#

Field, Values table
FieldValues
Unii76I7G6D29C
Rxcui830196

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

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