clomipramine hydrochloride

Generic: clomipramine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clomipramine hydrochloride
Generic Name clomipramine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

clomipramine hydrochloride 75 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-685
Product ID 16571-685_90156b43-61b5-41ef-87e9-e044f5864a2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212285
Listing Expiration 2026-12-31
Marketing Start 2020-11-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571685
Hyphenated Format 16571-685

Supplemental Identifiers

RxCUI
857297 857301 857305
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 ANDA212285 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (16571-685-01)
  • 30 CAPSULE in 1 BOTTLE (16571-685-03)
  • 90 CAPSULE in 1 BOTTLE (16571-685-09)
source: ndc

Packages (3)

16571-685-01 100 CAPSULE in 1 BOTTLE (16571-685-01) 16571-685-03 30 CAPSULE in 1 BOTTLE (16571-685-03) 16571-685-09 90 CAPSULE in 1 BOTTLE (16571-685-09)

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": "90156b43-61b5-41ef-87e9-e044f5864a2e", "openfda": {"unii": ["2LXW0L6GWJ"], "rxcui": ["857297", "857301", "857305"], "spl_set_id": ["bf37fdc5-f579-48c9-baa3-8e516ac71a33"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (16571-685-01)", "package_ndc": "16571-685-01", "marketing_start_date": "20201101"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (16571-685-03)", "package_ndc": "16571-685-03", "marketing_start_date": "20201101"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (16571-685-09)", "package_ndc": "16571-685-09", "marketing_start_date": "20201101"}], "brand_name": "Clomipramine Hydrochloride", "product_id": "16571-685_90156b43-61b5-41ef-87e9-e044f5864a2e", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "16571-685", "generic_name": "Clomipramine Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clomipramine Hydrochloride", "active_ingredients": [{"name": "CLOMIPRAMINE HYDROCHLORIDE", "strength": "75 mg/1"}], "application_number": "ANDA212285", "marketing_category": "ANDA", "marketing_start_date": "20201101", "listing_expiration_date": "20261231"}