clomipramine hydrochloride

Generic: clomipramine hydrochloride

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clomipramine hydrochloride
Generic Name clomipramine hydrochloride
Labeler leading pharma, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

clomipramine hydrochloride 75 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-165
Product ID 69315-165_48996a58-a312-4a01-ba38-0261a18bec65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211364
Listing Expiration 2026-12-31
Marketing Start 2020-03-10

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315165
Hyphenated Format 69315-165

Supplemental Identifiers

RxCUI
857297 857301 857305
UPC
0369315167014 0369315167038 0369315165034 0369315167090
UNII
2LXW0L6GWJ

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 clomipramine hydrochloride (source: ndc)
Generic Name clomipramine hydrochloride (source: ndc)
Application Number ANDA211364 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (69315-165-01)
  • 30 CAPSULE in 1 BOTTLE (69315-165-03)
source: ndc

Packages (2)

69315-165-01 100 CAPSULE in 1 BOTTLE (69315-165-01) 69315-165-03 30 CAPSULE in 1 BOTTLE (69315-165-03)

Ingredients (1)

clomipramine hydrochloride (75 mg/1)

Linked Drug Pages (1)

Clomipramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48996a58-a312-4a01-ba38-0261a18bec65", "openfda": {"upc": ["0369315167014", "0369315167038", "0369315165034", "0369315167090"], "unii": ["2LXW0L6GWJ"], "rxcui": ["857297", "857301", "857305"], "spl_set_id": ["fa0d4de8-c96e-429d-a65c-928afbf46863"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (69315-165-01)", "package_ndc": "69315-165-01", "marketing_start_date": "20200310"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (69315-165-03)", "package_ndc": "69315-165-03", "marketing_start_date": "20200310"}], "brand_name": "Clomipramine Hydrochloride", "product_id": "69315-165_48996a58-a312-4a01-ba38-0261a18bec65", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "69315-165", "generic_name": "Clomipramine Hydrochloride", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clomipramine Hydrochloride", "active_ingredients": [{"name": "CLOMIPRAMINE HYDROCHLORIDE", "strength": "75 mg/1"}], "application_number": "ANDA211364", "marketing_category": "ANDA", "marketing_start_date": "20200310", "listing_expiration_date": "20261231"}