dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

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

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 20 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-720
Product ID 59651-720_d81b93f8-bebc-455e-82b6-9a3de3f82e92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040317
Listing Expiration 2026-12-31
Marketing Start 2023-04-25

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651720
Hyphenated Format 59651-720

Supplemental Identifiers

RxCUI
991086
UNII
CQ903KQA31

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 dicyclomine hydrochloride (source: ndc)
Generic Name dicyclomine hydrochloride (source: ndc)
Application Number ANDA040317 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-720-01)
  • 1000 TABLET in 1 BOTTLE (59651-720-99)
source: ndc

Packages (2)

59651-720-01 100 TABLET in 1 BOTTLE (59651-720-01) 59651-720-99 1000 TABLET in 1 BOTTLE (59651-720-99)

Ingredients (1)

dicyclomine hydrochloride (20 mg/1)

Linked Drug Pages (1)

Dicyclomine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d81b93f8-bebc-455e-82b6-9a3de3f82e92", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991086"], "spl_set_id": ["d81b93f8-bebc-455e-82b6-9a3de3f82e92"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-720-01)", "package_ndc": "59651-720-01", "marketing_start_date": "20230425"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (59651-720-99)", "package_ndc": "59651-720-99", "marketing_start_date": "20230425"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "59651-720_d81b93f8-bebc-455e-82b6-9a3de3f82e92", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "59651-720", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA040317", "marketing_category": "ANDA", "marketing_start_date": "20230425", "listing_expiration_date": "20261231"}