dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 20 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-200
Product ID 24979-200_d1cace55-0a40-4a47-a4d9-d57ed5035686
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216782
Listing Expiration 2027-12-31
Marketing Start 2023-07-01

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24979200
Hyphenated Format 24979-200

Supplemental Identifiers

RxCUI
991086
UPC
0324979200033 0324979200019
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 ANDA216782 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (24979-200-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (24979-200-02)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (24979-200-03)
source: ndc

Packages (3)

24979-200-01 100 TABLET in 1 BOTTLE, PLASTIC (24979-200-01) 24979-200-02 500 TABLET in 1 BOTTLE, PLASTIC (24979-200-02) 24979-200-03 1000 TABLET in 1 BOTTLE, PLASTIC (24979-200-03)

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": "d1cace55-0a40-4a47-a4d9-d57ed5035686", "openfda": {"upc": ["0324979200033", "0324979200019"], "unii": ["CQ903KQA31"], "rxcui": ["991086"], "spl_set_id": ["ceba627b-5fe2-4ab3-b3bc-d90c3a170a93"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (24979-200-01)", "package_ndc": "24979-200-01", "marketing_start_date": "20230701"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (24979-200-02)", "package_ndc": "24979-200-02", "marketing_start_date": "20230701"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (24979-200-03)", "package_ndc": "24979-200-03", "marketing_start_date": "20230701"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "24979-200_d1cace55-0a40-4a47-a4d9-d57ed5035686", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "24979-200", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA216782", "marketing_category": "ANDA", "marketing_start_date": "20230701", "listing_expiration_date": "20271231"}