🇺🇸
United States · US · US:70069-441_a927b130-5b1b-462f-bb0c-2ea8763487ee
DICYCLOMINE HYDROCHLORIDE
Orange BookUNIISPLATC A03AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeA03AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170069441055 AMPULE in 1 CARTON (70069-441-05) / 2 mL in 1 AMPULE (70069-441-01)
Annotations
UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A214333
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": "70069-441_a927b130-5b1b-462f-bb0c-2ea8763487ee",
"productndc": "70069-441",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "214333",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Nov 1, 2024"
}
],
"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": "ANDA214333",
"marketing_category": "ANDA",
"nonproprietary_name": "DICYCLOMINE HYDROCHLORIDE",
"start_marketing_date": "20241105",
"active_numerator_strength": "10"
}Related drugs
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