dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 20 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-428
Product ID 62135-428_241f85bb-925f-a594-e063-6394a90a92fd
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 62135428
Hyphenated Format 62135-428

Supplemental Identifiers

RxCUI
991061 991086
UPC
0362135428129 0362135428013 0362135718909
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 ANDA040230 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (62135-428-01)
  • 120 TABLET in 1 BOTTLE (62135-428-12)
source: ndc

Packages (2)

62135-428-01 100 TABLET in 1 BOTTLE (62135-428-01) 62135-428-12 120 TABLET in 1 BOTTLE (62135-428-12)

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": "241f85bb-925f-a594-e063-6394a90a92fd", "openfda": {"upc": ["0362135428129", "0362135428013", "0362135718909"], "unii": ["CQ903KQA31"], "rxcui": ["991061", "991086"], "spl_set_id": ["d628ac1c-404d-45eb-8aab-0e550c95ed4a"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (62135-428-01)", "package_ndc": "62135-428-01", "marketing_start_date": "20230313"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (62135-428-12)", "package_ndc": "62135-428-12", "marketing_start_date": "20221205"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "62135-428_241f85bb-925f-a594-e063-6394a90a92fd", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "62135-428", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Chartwell RX, 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"}