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United States · US · US:43353-083_a923a016-80b4-4a98-9494-ada455890843
Diphenoxylate Hydrochloride and Atropine Sulfate
In shortageOrange BookUNIISPLATC A03BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeA03BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11433530833030 TABLET in 1 BOTTLE (43353-083-30)
- ndc11433530835360 TABLET in 1 BOTTLE (43353-083-53)
- ndc11433530836090 TABLET in 1 BOTTLE (43353-083-60)
- ndc114335308370120 TABLET in 1 BOTTLE (43353-083-70)
- ndc114335308380180 TABLET in 1 BOTTLE (43353-083-80)
- ndc114335308390240 TABLET in 1 BOTTLE (43353-083-90)
Annotations
UNII (FDA Substance ID)
03J5ZE7KA5
ATROPINE SULFATE
RxCUI 153971
Orange Book
N012462
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": "43353-083_a923a016-80b4-4a98-9494-ada455890843",
"productndc": "43353-083",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "012462",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "0.025MG;2.5MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"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": "NDA012462",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE",
"start_marketing_date": "20130227",
"active_numerator_strength": ".025; 2.5"
}Related drugs
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