Imipramine Hydrochloride

Product NDC
50090-0035
11-digit product format
500900035
Labeler code
50090
Product ID
50090-0035_4886b22d-4c0b-4cd2-b9de-916cc5513414
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA081049
Marketing category
ANDA
Marketing start
1990-06-05
Marketing end
0000-00-00
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0035-02020-01-31C16284748780-19d75b9d0-8d94-f424-e053-dadaa90a57ceIMIPRAMINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0035-0Imipramine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Imipramine HydrochlorideACTIVE INGREDIENTBKE5Q1J60UIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
ImipramineACTIVE MOIETYOGG85SX4E4IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
calcium phosphate, dibasic, anhydrousINACTIVE INGREDIENTL11K75P92JIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
FD&C red No. 40INACTIVE INGREDIENTWZB9127XOAIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
FD&C yellow No. 6INACTIVE INGREDIENTH77VEI93A8IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0035IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20170828_a545ec43-0869-4f7d-81ca-34215ff6ad76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835564imipramine HCl 25 MG Oral TabletPSNa545ec43-0869-4f7d-81ca-34215ff6ad764
835564imipramine hydrochloride 25 MG Oral TabletSCDa545ec43-0869-4f7d-81ca-34215ff6ad764

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-0035-05009000350030 in 1 BOTTLE, PLASTICHistorical