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United States · US · US:63629-3031_761159a0-fffc-43ca-b8bf-66f205460960

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 · 10

  • ndc11
    6362930310
    100 TABLET in 1 BOTTLE (63629-3031-0)
  • ndc11
    6362930311
    30 TABLET in 1 BOTTLE (63629-3031-1)
  • ndc11
    6362930312
    120 TABLET in 1 BOTTLE (63629-3031-2)
  • ndc11
    6362930313
    60 TABLET in 1 BOTTLE (63629-3031-3)
  • ndc11
    6362930314
    90 TABLET in 1 BOTTLE (63629-3031-4)
  • ndc11
    6362930315
    40 TABLET in 1 BOTTLE (63629-3031-5)
  • ndc11
    6362930316
    20 TABLET in 1 BOTTLE (63629-3031-6)
  • ndc11
    6362930317
    112 TABLET in 1 BOTTLE (63629-3031-7)
  • ndc11
    6362930318
    84 TABLET in 1 BOTTLE (63629-3031-8)
  • ndc11
    6362930319
    15 TABLET in 1 BOTTLE (63629-3031-9)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040419
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": "63629-3031_761159a0-fffc-43ca-b8bf-66f205460960",
  "productndc": "63629-3031",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040419",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;15MG",
        "product_no": "001",
        "approval_date": "May 31, 2001"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;30MG",
        "product_no": "002",
        "approval_date": "May 31, 2001"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;60MG",
        "product_no": "003",
        "approval_date": "May 31, 2001"
      }
    ],
    "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": "ANDA040419",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetaminophen and codeine phosphate",
  "start_marketing_date": "20010531",
  "active_numerator_strength": "300; 60"
}

Related drugs

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