Imipramine Hydrochloride

Product NDC
53489-331
11-digit product format
534890331
Labeler code
53489
Product ID
53489-331_9e0586d7-3835-4ee5-9bff-141344f3e611
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA081049
Marketing category
ANDA
Marketing start
1990-06-05
Marketing end
2020-12-31
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-331-01EA - Each53489-3316af925ca-d5d4-47b6-a603-0c8c4acd4a6a12012-07-24

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 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