🇺🇸
United States · US · US:0517-1980_9ffbe6bb-e13f-48d4-a8e0-55936b5167dd
Dicyclomine hydrochloride
Orange BookUNIISPLATC A03AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Regent, Inc.
CountryUS (United States)
ATC codeA03AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1105171980055 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01)
- ndc11051719801010 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01)
Annotations
UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A208353
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": "0517-1980_9ffbe6bb-e13f-48d4-a8e0-55936b5167dd",
"productndc": "0517-1980",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "208353",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Feb 17, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DICYCLOMINE HYDROCHLORIDE",
"proprietary_name": "Dicyclomine hydrochloride",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA208353",
"marketing_category": "ANDA",
"nonproprietary_name": "Dicyclomine hydrochloride",
"start_marketing_date": "20170901",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A03AA07.
- 🇺🇸DicyclomineNuCare Pharmaceuticals, Inc.
- 🇺🇸DicyclomineHikma Pharmaceuticals USA Inc.
- 🇺🇸dicyclomine hydrochloridePar Health USA, LLC
- 🇺🇸Dicyclomine hydrochlorideCamber Pharmaceuticals, Inc.
- 🇺🇸Dicyclomine hydrochlorideTrifluent Pharma, LLC
- 🇺🇸Dicyclomine hydrochlorideRising Pharma Holdings, Inc.
- 🇺🇸Dicyclomine hydrochlorideNCS HealthCare of KY, LLC dba Vangard Labs
- 🇺🇸Dicyclomine hydrochlorideBryant Ranch Prepack
Access this data programmatically
Query Dicyclomine hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.