dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-209
Product ID 71610-209_dcd1f50a-a200-48b3-89f7-039081a9e72d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040230
Listing Expiration 2026-12-31
Marketing Start 1999-02-26

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610209
Hyphenated Format 71610-209

Supplemental Identifiers

RxCUI
991086
UNII
CQ903KQA31

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 ANDA040230 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 9000 TABLET in 1 BOTTLE (71610-209-09)
source: ndc

Packages (1)

71610-209-09 9000 TABLET in 1 BOTTLE (71610-209-09)

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": "dcd1f50a-a200-48b3-89f7-039081a9e72d", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991086"], "spl_set_id": ["da2c43f8-1c3a-447f-8994-f9899fb5e141"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 TABLET in 1 BOTTLE (71610-209-09)", "package_ndc": "71610-209-09", "marketing_start_date": "20181218"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "71610-209_dcd1f50a-a200-48b3-89f7-039081a9e72d", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "71610-209", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA040230", "marketing_category": "ANDA", "marketing_start_date": "19990226", "listing_expiration_date": "20261231"}