Imipramine Hydrochloride

Product NDC
68180-311
11-digit product format
681800311
Labeler code
68180
Product ID
68180-311_b891d3a3-3346-441e-99cc-03528b4afa46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA090443
Marketing category
ANDA
Marketing start
2010-12-21
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
10 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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIPRAMINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBKE5Q1J60U
Rxcui835564, 835568, 835593

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
68180-311-01Imipramine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1008
68180-311-02Imipramine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-311-01EA - Each68180-311310e81ba-e502-4f39-b137-4ba7352a3a4712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IMIPRAMINE HYDROCHLORIDEACTIVE INGREDIENTBKE5Q1J60UIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
IMIPRAMINEACTIVE MOIETYOGG85SX4E4IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4
IMIPRAMINE HYDROCHLORIDEACTIVE INGREDIENTBKE5Q1J60UIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
IMIPRAMINEACTIVE MOIETYOGG85SX4E4IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-311IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20231216_55311747-710c-43c4-821d-76323ff2520e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835593imipramine HCl 10 MG Oral TabletPSN55311747-710c-43c4-821d-76323ff2520e8
835564imipramine HCl 25 MG Oral TabletPSN55311747-710c-43c4-821d-76323ff2520e8
835568imipramine HCl 50 MG Oral TabletPSN55311747-710c-43c4-821d-76323ff2520e8
835593imipramine hydrochloride 10 MG Oral TabletSCD55311747-710c-43c4-821d-76323ff2520e8
835564imipramine hydrochloride 25 MG Oral TabletSCD55311747-710c-43c4-821d-76323ff2520e8
835568imipramine hydrochloride 50 MG Oral TabletSCD55311747-710c-43c4-821d-76323ff2520e8
835593imipramine HCl 10 MG Oral TabletPSNf1cfdf51-5211-4b31-9ac0-d06a3997ac8c1
835564imipramine HCl 25 MG Oral TabletPSNf1cfdf51-5211-4b31-9ac0-d06a3997ac8c1
835568imipramine HCl 50 MG Oral TabletPSNf1cfdf51-5211-4b31-9ac0-d06a3997ac8c1
835593imipramine hydrochloride 10 MG Oral TabletSCDf1cfdf51-5211-4b31-9ac0-d06a3997ac8c1
835564imipramine hydrochloride 25 MG Oral TabletSCDf1cfdf51-5211-4b31-9ac0-d06a3997ac8c1
835568imipramine hydrochloride 50 MG Oral TabletSCDf1cfdf51-5211-4b31-9ac0-d06a3997ac8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68180-311-0168180031101100 in 1 BOTTLEHistorical
68180-311-0268180031102500 in 1 BOTTLEHistorical