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United States · US · US:0832-6053_4368e60e-34d6-f0c2-e063-6294a90a1dbd
Dicyclomine hydrochloride
Orange BookUNIISPLATC A03AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeA03AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1108326053101000 CAPSULE in 1 BOTTLE (0832-6053-10)
- ndc110832605311100 CAPSULE in 1 BOTTLE (0832-6053-11)
Annotations
UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A216639
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": "0832-6053_4368e60e-34d6-f0c2-e063-6294a90a1dbd",
"productndc": "0832-6053",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "216639",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Mar 24, 2023"
}
],
"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": "ANDA216639",
"marketing_category": "ANDA",
"nonproprietary_name": "Dicyclomine hydrochloride",
"start_marketing_date": "20230324",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A03AA07.
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