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United States · US · US:49483-699_02a5f067-4b67-ecc7-e063-6294a90a92c3
Acetaminophen
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTIME CAP LABORATORIES, INC.
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc114948369901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-01)
- ndc11494836990550 BOTTLE in 1 CARTON (49483-699-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc114948369926225 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-26)
- ndc114948369940400 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-40)
- ndc1149483699421 BOTTLE in 1 CARTON (49483-699-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A215486
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": {
"44520aa1-b63f-4239-e063-6394a90a5e14": {
"match": "brand_token",
"title": "ACETAMINOPHEN LIQUID / ACETAMINOPHEN DIPHENHYDRAMINE HCL LIQUID (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [KROGER]",
"spl_version": "2",
"published_date": "2026-06-02"
}
},
"productid": "49483-699_02a5f067-4b67-ecc7-e063-6294a90a92c3",
"productndc": "49483-699",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "215486",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "650MG",
"product_no": "001",
"approval_date": "Aug 25, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN",
"proprietary_name": "Acetaminophen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215486",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen tablet extended release",
"start_marketing_date": "20211004",
"active_numerator_strength": "650"
}Related drugs
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