🇺🇸
United States · US · US:72888-198_4b7e07c5-f687-74a5-e063-6294a90aa7ef
Dicyclomine hydrochloride
Orange BookUNIISPLATC A03AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvagen Pharma Ltd.,
CountryUS (United States)
ATC codeA03AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1172888198001000 TABLET in 1 BOTTLE (72888-198-00)
- ndc117288819801100 TABLET in 1 BOTTLE (72888-198-01)
- ndc117288819805500 TABLET in 1 BOTTLE (72888-198-05)
- ndc117288819812120 TABLET in 1 BOTTLE (72888-198-12)
- ndc11728881983030 TABLET in 1 BOTTLE (72888-198-30)
Annotations
UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A216736
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "CQ903KQA31",
"rxcui": "152021",
"inchikey": "GUBNMFJOJGDCEL-UHFFFAOYSA-N",
"display_name": "DICYCLOMINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"bb099db9-f635-4a64-8892-6236971dec45": {
"match": "brand_token",
"title": "DICYCLOMINE HYDROCHLORIDE SOLUTION [PAR HEALTH USA, LLC]",
"spl_version": "8",
"published_date": "2026-05-21"
}
},
"productid": "72888-198_4b7e07c5-f687-74a5-e063-6294a90aa7ef",
"productndc": "72888-198",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216736",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Dec 14, 2022"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "40MG",
"product_no": "002",
"approval_date": "Mar 25, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DICYCLOMINE HYDROCHLORIDE",
"proprietary_name": "Dicyclomine hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216736",
"marketing_category": "ANDA",
"nonproprietary_name": "Dicyclomine hydrochloride",
"start_marketing_date": "20250325",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A03AA07.
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- 🇺🇸Dicyclomine hydrochlorideTrifluent Pharma, LLC
- 🇺🇸Dicyclomine hydrochlorideRising Pharma Holdings, Inc.
- 🇺🇸Dicyclomine hydrochlorideNCS HealthCare of KY, LLC dba Vangard Labs
- 🇺🇸Dicyclomine hydrochlorideBryant Ranch Prepack
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