🇺🇸
United States · US · US:70518-3917_4aa0eee6-1269-e6ee-e063-6294a90a4db1
Dicyclomine Hydrochloride
Orange BookUNIISPLATC A03AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeA03AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11705183917030 TABLET in 1 BLISTER PACK (70518-3917-0)
- ndc117051839171180 TABLET in 1 BOTTLE, PLASTIC (70518-3917-1)
- ndc11705183917230 TABLET in 1 BLISTER PACK (70518-3917-2)
- ndc11705183917320 TABLET in 1 BOTTLE, PLASTIC (70518-3917-3)
- ndc117051839174180 TABLET in 1 BOTTLE, PLASTIC (70518-3917-4)
Annotations
UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A216782
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": "70518-3917_4aa0eee6-1269-e6ee-e063-6294a90a4db1",
"productndc": "70518-3917",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216782",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Jun 1, 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": "ANDA216782",
"marketing_category": "ANDA",
"nonproprietary_name": "Dicyclomine Hydrochloride",
"start_marketing_date": "20231119",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A03AA07.
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- 🇺🇸Dicyclomine hydrochlorideRising Pharma Holdings, Inc.
- 🇺🇸Dicyclomine hydrochlorideNCS HealthCare of KY, LLC dba Vangard Labs
- 🇺🇸Dicyclomine hydrochlorideBryant Ranch Prepack
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