FDA.reportPublic FDA data

Imipramine Hydrochloride

Product NDC
64380-169
11-digit product format
643800169
Labeler code
64380
Product ID
64380-169_07bb51f0-34dd-43fa-8364-9223e58bdb6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA088292
Marketing category
ANDA
Marketing start
2022-04-11
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Imipramine Hydrochloride
Listing expiration
2027-12-31

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
64380-169-01Imipramine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1005
64380-169-02Imipramine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-169-01EA - Each64380-169a20117a6-3d9a-4270-8bb4-8c04bcdd33fb12022-05-04
64380-169-02EA - Each64380-1695f9c3c3e-0dfe-492e-bec8-54a2e4240dbc12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-169IMIPRAMINE HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]3Current NDC, Legacy NDC, 2 package rows20230530_51d3b181-0d15-4782-a966-feb137972b18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835593imipramine HCl 10 MG Oral TabletPSN51d3b181-0d15-4782-a966-feb137972b185
835564imipramine HCl 25 MG Oral TabletPSN51d3b181-0d15-4782-a966-feb137972b185
835568imipramine HCl 50 MG Oral TabletPSN51d3b181-0d15-4782-a966-feb137972b185
835593imipramine hydrochloride 10 MG Oral TabletSCD51d3b181-0d15-4782-a966-feb137972b185
835564imipramine hydrochloride 25 MG Oral TabletSCD51d3b181-0d15-4782-a966-feb137972b185
835568imipramine hydrochloride 50 MG Oral TabletSCD51d3b181-0d15-4782-a966-feb137972b185

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-169-0164380016901100 TABLET in 1 BOTTLE, PLASTIC (64380-169-01) 100 tablet2022-04-110000-00-00NoNoCurrent
64380-169-02643800169021000 TABLET in 1 BOTTLE, PLASTIC (64380-169-02) 1000 tablet2022-04-110000-00-00NoNoCurrent