🇺🇸
United States · US · US:69238-1993_f3869a7a-b5f3-4279-b07b-ff01a8c2a286
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE
Orange BookUNIISPLATC A01AD
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York, LLC
CountryUS (United States)
ATC codeA01AD
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116923819931100 CAPSULE in 1 BOTTLE (69238-1993-1)
Annotations
UNII (FDA Substance ID)
R16CO5Y76E
ASPIRIN
RxCUI 1191
Orange Book
A074951
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "R16CO5Y76E",
"rxcui": "1191",
"inchikey": "BSYNRYMUTXBXSQ-UHFFFAOYSA-N",
"display_name": "ASPIRIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"95a33c9b-79a6-47c7-8433-fc217950b88f": {
"match": "brand_token",
"title": "BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]",
"spl_version": "16",
"published_date": "2026-05-28"
}
},
"productid": "69238-1993_f3869a7a-b5f3-4279-b07b-ff01a8c2a286",
"productndc": "69238-1993",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "074951",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "325MG;50MG;40MG;30MG",
"product_no": "001",
"approval_date": "Aug 31, 1998"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
"proprietary_name": "BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE",
"active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "ANDA074951",
"marketing_category": "ANDA",
"nonproprietary_name": "BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE",
"start_marketing_date": "20190401",
"active_numerator_strength": "325; 50; 40; 30"
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