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United States · US · US:67296-1485_2c62c754-969a-47f7-e063-6294a90a94fe
Diphenoxylate Hydrochloride and Atropine Sulfate
In shortageOrange BookUNIISPLATC A03BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRedpharm Drug Inc.
CountryUS (United States)
ATC codeA03BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116729614859100 TABLET in 1 BOTTLE (67296-1485-9)
Annotations
UNII (FDA Substance ID)
03J5ZE7KA5
ATROPINE SULFATE
RxCUI 153971
Orange Book
A213413
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Atropine Sulfate Injection
Raw payload (JSON)
{
"unii": {
"unii": "03J5ZE7KA5",
"rxcui": "153971",
"inchikey": "JPKKQJKQTPNWTR-WFEZVHBLSA-N;JPKKQJKQTPNWTR-AAWIVWGASA-N",
"display_name": "ATROPINE SULFATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"bd08ed90-dd26-4629-83c0-0f75af6ebb95": {
"match": "brand_token",
"title": "DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "8",
"published_date": "2026-05-25"
}
},
"productid": "67296-1485_2c62c754-969a-47f7-e063-6294a90a94fe",
"productndc": "67296-1485",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213413",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "0.025MG;2.5MG",
"product_no": "001",
"approval_date": "Feb 20, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE",
"shortage_reason": "Atropine Sulfate Injection",
"shortage_status": "current",
"proprietary_name": "Diphenoxylate Hydrochloride and Atropine Sulfate",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA213413",
"marketing_category": "ANDA",
"nonproprietary_name": "diphenoxylate hydrochloride and atropine sulfate",
"start_marketing_date": "20200315",
"active_numerator_strength": ".025; 2.5"
}Related drugs
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