🇺🇸
United States · US · US:43063-045_2b247a51-9783-e240-e063-6294a90a8907
Dicyclomine Hydrochloride
Orange BookUNIISPLATC A03AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA03AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1143063045044 TABLET in 1 BOTTLE, PLASTIC (43063-045-04)
- ndc1143063045066 TABLET in 1 BOTTLE, PLASTIC (43063-045-06)
- ndc11430630452020 TABLET in 1 BOTTLE, PLASTIC (43063-045-20)
- ndc11430630453030 TABLET in 1 BOTTLE, PLASTIC (43063-045-30)
- ndc11430630456060 TABLET in 1 BOTTLE, PLASTIC (43063-045-60)
Annotations
UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A085223
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": "43063-045_2b247a51-9783-e240-e063-6294a90a8907",
"productndc": "43063-045",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "085223",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Jul 30, 1986"
}
],
"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": "ANDA085223",
"marketing_category": "ANDA",
"nonproprietary_name": "Dicyclomine Hydrochloride",
"start_marketing_date": "19860730",
"active_numerator_strength": "20"
}Related drugs
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