🇺🇸
United States · US · US:0641-6173_856c880c-b430-43a3-a225-1fb783b6c0ea
Dicyclomine Hydrochloride
Orange BookUNIISPLATC A03AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA03AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11064161731010 VIAL, SINGLE-DOSE in 1 CARTON (0641-6173-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6173-01)
Annotations
UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A040465
AP
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": "INTRAMUSCULAR",
"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": "0641-6173_856c880c-b430-43a3-a225-1fb783b6c0ea",
"productndc": "0641-6173",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "040465",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Jun 30, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DICYCLOMINE HYDROCHLORIDE",
"proprietary_name": "Dicyclomine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA040465",
"marketing_category": "ANDA",
"nonproprietary_name": "Dicyclomine Hydrochloride",
"start_marketing_date": "20151230",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A03AA07.
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