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United States · US · US:17856-2261_362374f1-a8ef-120d-e063-6394a90a0d6d
Dicyclomine Hydrochloride
Orange BookUNIISPLATC A03AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerATLANTIC BIOLOGICALS CORP.
CountryUS (United States)
ATC codeA03AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11178562261172 mL in 1 BOX, UNIT-DOSE (17856-2261-1)
- ndc11178562261272 mL in 1 BOX, UNIT-DOSE (17856-2261-2)
Annotations
UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A214721
AA
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": "17856-2261_362374f1-a8ef-120d-e063-6394a90a0d6d",
"productndc": "17856-2261",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "214721",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "001",
"approval_date": "Apr 23, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DICYCLOMINE HYDROCHLORIDE",
"proprietary_name": "Dicyclomine Hydrochloride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA214721",
"marketing_category": "ANDA",
"nonproprietary_name": "Dicyclomine Hydrochloride",
"start_marketing_date": "20250304",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A03AA07.
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