🇺🇸
United States · US · US:50268-199_47e343c9-2e61-c288-e063-6394a90a0b5c
Dicyclomine Hydrochloride
Orange BookUNIISPLATC A03AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvPAK
CountryUS (United States)
ATC codeA03AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11502681991550 BLISTER PACK in 1 BOX (50268-199-15) / 1 CAPSULE in 1 BLISTER PACK (50268-199-11)
Annotations
UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A217054
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": "50268-199_47e343c9-2e61-c288-e063-6394a90a0b5c",
"productndc": "50268-199",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "217054",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Dec 27, 2022"
}
],
"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": "ANDA217054",
"marketing_category": "ANDA",
"nonproprietary_name": "Dicyclomine Hydrochloride",
"start_marketing_date": "20240320",
"active_numerator_strength": "10"
}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
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