🇺🇸
United States · US · US:16571-259_c68c26a1-6f4c-4853-9e9d-1e2e2e3d5a6c
Dicyclomine hydrochloride
Orange BookUNIISPLATC A03AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA03AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111657125901100 TABLET in 1 BOTTLE (16571-259-01)
- ndc1116571259101000 TABLET in 1 BOTTLE (16571-259-10)
Annotations
UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A218952
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": "16571-259_c68c26a1-6f4c-4853-9e9d-1e2e2e3d5a6c",
"productndc": "16571-259",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218952",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Nov 15, 2024"
}
],
"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": "ANDA218952",
"marketing_category": "ANDA",
"nonproprietary_name": "Dicyclomine hydrochloride",
"start_marketing_date": "20241115",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A03AA07.
- 🇺🇸DicyclomineNuCare Pharmaceuticals, Inc.
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- 🇺🇸dicyclomine hydrochloridePar Health USA, LLC
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- 🇺🇸Dicyclomine hydrochlorideCamber Pharmaceuticals, Inc.
- 🇺🇸Dicyclomine hydrochlorideNCS HealthCare of KY, LLC dba Vangard Labs
- 🇺🇸Dicyclomine hydrochlorideBryant Ranch Prepack
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