dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 20 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4393
Product ID 70518-4393_3a0ce845-ca16-a1f1-e063-6294a90ab259
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040317
Listing Expiration 2026-12-31
Marketing Start 2025-07-16

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184393
Hyphenated Format 70518-4393

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 ANDA040317 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-4393-0)
source: ndc

Packages (1)

70518-4393-0 30 TABLET in 1 BLISTER PACK (70518-4393-0)

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": "3a0ce845-ca16-a1f1-e063-6294a90ab259", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991086"], "spl_set_id": ["62be6437-db8c-431b-8e5f-780487cf2d43"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-4393-0)", "package_ndc": "70518-4393-0", "marketing_start_date": "20250716"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "70518-4393_3a0ce845-ca16-a1f1-e063-6294a90ab259", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "70518-4393", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "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": "20250716", "listing_expiration_date": "20261231"}