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United States · US · US:63629-1190_44718767-e131-4f39-879e-8628abe64d87

ACETAMINOPHEN AND CODEINE PHOSPHATE

In shortageOrange BookUNIISPLATC N02BE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6362911901
    500 TABLET in 1 BOTTLE (63629-1190-1)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A211610
AAAAAA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
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": "63629-1190_44718767-e131-4f39-879e-8628abe64d87",
  "productndc": "63629-1190",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211610",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;15MG",
        "product_no": "001",
        "approval_date": "Jun 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;30MG",
        "product_no": "002",
        "approval_date": "Jun 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;60MG",
        "product_no": "003",
        "approval_date": "Jun 27, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; CODEINE PHOSPHATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211610",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetaminophen and codeine phosphate",
  "start_marketing_date": "20190802",
  "active_numerator_strength": "300; 60"
}

Related drugs

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