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United States · US · US:53329-197_1cd8105b-61d9-1400-e063-6394a90a8422
Medline
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMedline Industries, LP
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11533291972950 TABLET, EXTENDED RELEASE in 1 BOTTLE (53329-197-29)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A211544
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "362O9ITL9D",
"rxcui": "161",
"inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
"display_name": "ACETAMINOPHEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"494d7e97-a3a8-2c7a-e063-6394a90a3ae1": {
"match": "brand_token",
"title": "MEDLINE (POVIDONE-IODINE) SWAB [MEDLINE INDUSTRIES, LP]",
"spl_version": "2",
"published_date": "2026-04-22"
}
},
"productid": "53329-197_1cd8105b-61d9-1400-e063-6394a90a8422",
"productndc": "53329-197",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "211544",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "650MG",
"product_no": "001",
"approval_date": "Apr 16, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN",
"proprietary_name": "Medline",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211544",
"marketing_category": "ANDA",
"nonproprietary_name": "acetaminophen",
"start_marketing_date": "20240701",
"active_numerator_strength": "650"
}Related drugs
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