Imipramine Pamoate

Product NDC
0054-0273
11-digit product format
000540273
Labeler code
0054
Product ID
0054-0273_9c97ff7a-cee1-4c19-a52e-3f22798834fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc
Application
ANDA091099
Marketing category
ANDA
Marketing start
2010-04-19
Substance
IMIPRAMINE PAMOATE
Active strength
75 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Imipramine Pamoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIPRAMINE PAMOATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMC34P30298
Rxcui835572, 835577, 835589, 835591

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0e0df1b-51aa-4301-873c-732ab0ec1631Product name120170614
0c52f100-e529-4cfc-bd59-334f3eea0233Product name120151110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0273-13Imipramine Pamoate30 in 1 BOTTLECAPSULE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0273-13EA - Each0054-0273db12c7b2-46c9-4f68-b69f-1c1444df5c2112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IMIPRAMINE PAMOATEACTIVE INGREDIENTMC34P30298IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
IMIPRAMINEACTIVE MOIETYOGG85SX4E4IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GIMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDIMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MIMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5HIMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
GELATININACTIVE INGREDIENT2G86QN327LIMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UIMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0273IMIPRAMINE PAMOATE CAPSULE [HIKMA PHARMACEUTICALS USA INC]8Current NDC, Legacy NDC, 1 package rows20250403_6e780825-2a66-41fd-a04c-78fa7c4df05e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835591imipramine pamoate 100 MG Oral CapsulePSN6e780825-2a66-41fd-a04c-78fa7c4df05e9
835589imipramine pamoate 125 MG Oral CapsulePSN6e780825-2a66-41fd-a04c-78fa7c4df05e9
835577imipramine pamoate 150 MG Oral CapsulePSN6e780825-2a66-41fd-a04c-78fa7c4df05e9
835572imipramine pamoate 75 MG Oral CapsulePSN6e780825-2a66-41fd-a04c-78fa7c4df05e9
835591imipramine pamoate 100 MG Oral CapsuleSCD6e780825-2a66-41fd-a04c-78fa7c4df05e9
835589imipramine pamoate 125 MG Oral CapsuleSCD6e780825-2a66-41fd-a04c-78fa7c4df05e9
835577imipramine pamoate 150 MG Oral CapsuleSCD6e780825-2a66-41fd-a04c-78fa7c4df05e9
835572imipramine pamoate 75 MG Oral CapsuleSCD6e780825-2a66-41fd-a04c-78fa7c4df05e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0273-130005402731330 CAPSULE in 1 BOTTLE (0054-0273-13) 30 capsule2010-04-190000-00-00NoNoCurrent