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United States · US · US:71610-714_d2906ede-d6cd-449f-83ac-a087b2cec958
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
- ndc11716107143030 TABLET in 1 BOTTLE (71610-714-30)
- ndc11716107145360 TABLET in 1 BOTTLE (71610-714-53)
- ndc11716107146090 TABLET in 1 BOTTLE (71610-714-60)
- ndc117161071470120 TABLET in 1 BOTTLE (71610-714-70)
- ndc117161071480180 TABLET in 1 BOTTLE (71610-714-80)
- ndc117161071490240 TABLET in 1 BOTTLE (71610-714-90)
Annotations
UNII (FDA Substance ID)
03J5ZE7KA5
ATROPINE SULFATE
RxCUI 153971
Orange Book
A213335
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": "71610-714_d2906ede-d6cd-449f-83ac-a087b2cec958",
"productndc": "71610-714",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213335",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "0.025MG;2.5MG",
"product_no": "001",
"approval_date": "Oct 6, 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": "ANDA213335",
"marketing_category": "ANDA",
"nonproprietary_name": "diphenoxylate hydrochloride and atropine sulfate",
"start_marketing_date": "20201030",
"active_numerator_strength": ".025; 2.5"
}Related drugs
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