🇺🇸
United States · US · US:68788-8751_00f785fd-3c18-4e62-a0c2-18ce7ae30f25
Dicyclomine Hydrochloride
Orange BookUNIISPLATC A03AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA03AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11687888751220 TABLET in 1 BOTTLE, PLASTIC (68788-8751-2)
- ndc11687888751330 TABLET in 1 BOTTLE, PLASTIC (68788-8751-3)
- ndc11687888751660 TABLET in 1 BOTTLE, PLASTIC (68788-8751-6)
- ndc11687888751990 TABLET in 1 BOTTLE, PLASTIC (68788-8751-9)
Annotations
UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A217916
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": "68788-8751_00f785fd-3c18-4e62-a0c2-18ce7ae30f25",
"productndc": "68788-8751",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "217916",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Aug 4, 2023"
}
],
"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": "ANDA217916",
"marketing_category": "ANDA",
"nonproprietary_name": "Dicyclomine Hydrochloride",
"start_marketing_date": "20230913",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A03AA07.
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- 🇺🇸DicyclomineHikma Pharmaceuticals USA Inc.
- 🇺🇸dicyclomine hydrochloridePar Health USA, LLC
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- 🇺🇸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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