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United States · US · US:49483-704_02a5f067-4b67-ecc7-e063-6294a90a92c3

Muscle Aches and Pains Acetaminophen extended release

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 · 1

  • ndc11
    4948370405
    1 BOTTLE in 1 CARTON (49483-704-05) / 50 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": {
    "163ba925-b26a-4737-8c05-68875435452b": {
      "match": "brand_token",
      "title": "MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [ALDERMED INC.]",
      "spl_version": "5",
      "published_date": "2026-05-11"
    }
  },
  "productid": "49483-704_02a5f067-4b67-ecc7-e063-6294a90a92c3",
  "productndc": "49483-704",
  "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": "Muscle Aches and Pains Acetaminophen extended release",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215486",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen",
  "start_marketing_date": "20221107",
  "active_numerator_strength": "650"
}

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