imipramine hydrochloride

Generic: imipramine hydrochloride

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imipramine hydrochloride
Generic Name imipramine hydrochloride
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

imipramine hydrochloride 10 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-169
Product ID 64380-169_07bb51f0-34dd-43fa-8364-9223e58bdb6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088292
Listing Expiration 2027-12-31
Marketing Start 2022-04-11

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380169
Hyphenated Format 64380-169

Supplemental Identifiers

RxCUI
835564 835568 835593
UPC
0364380169024 0364380170013 0364380169017 0364380171010 0364380171027 0364380170020
UNII
BKE5Q1J60U

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name imipramine hydrochloride (source: ndc)
Generic Name imipramine hydrochloride (source: ndc)
Application Number ANDA088292 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (64380-169-01)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (64380-169-02)
source: ndc

Packages (2)

64380-169-01 100 TABLET in 1 BOTTLE, PLASTIC (64380-169-01) 64380-169-02 1000 TABLET in 1 BOTTLE, PLASTIC (64380-169-02)

Ingredients (1)

imipramine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Imipramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "07bb51f0-34dd-43fa-8364-9223e58bdb6c", "openfda": {"upc": ["0364380169024", "0364380170013", "0364380169017", "0364380171010", "0364380171027", "0364380170020"], "unii": ["BKE5Q1J60U"], "rxcui": ["835564", "835568", "835593"], "spl_set_id": ["51d3b181-0d15-4782-a966-feb137972b18"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (64380-169-01)", "package_ndc": "64380-169-01", "marketing_start_date": "20220411"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (64380-169-02)", "package_ndc": "64380-169-02", "marketing_start_date": "20220411"}], "brand_name": "Imipramine Hydrochloride", "product_id": "64380-169_07bb51f0-34dd-43fa-8364-9223e58bdb6c", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "64380-169", "generic_name": "Imipramine Hydrochloride", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imipramine Hydrochloride", "active_ingredients": [{"name": "IMIPRAMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA088292", "marketing_category": "ANDA", "marketing_start_date": "20220411", "listing_expiration_date": "20271231"}