Amoxicillin

Orange BookUNIISPLATC J01CA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeJ01CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7051821900
28 CAPSULE in 1 BLISTER PACK (70518-2190-0)
ndc11
7051821901
21 CAPSULE in 1 BLISTER PACK (70518-2190-1)
ndc11
7051821902
30 CAPSULE in 1 BLISTER PACK (70518-2190-2)
ndc11
7051821903
30 CAPSULE in 1 BOTTLE, PLASTIC (70518-2190-3)
ndc11
7051821904
21 CAPSULE in 1 BOTTLE, PLASTIC (70518-2190-4)
ndc11
7051821905
20 CAPSULE in 1 BOTTLE, PLASTIC (70518-2190-5)
ndc11
7051821907
100 POUCH in 1 BOX (70518-2190-7) / 1 CAPSULE in 1 POUCH (70518-2190-6)
ndc11
7051821908
14 CAPSULE in 1 BOTTLE, PLASTIC (70518-2190-8)

Annotations

UNII (FDA Substance ID)

804826J2HU

AMOXICILLIN

RxCUI 133008

Orange Book

A064076

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "804826J2HU",
    "rxcui": "133008",
    "inchikey": "MQXQVCLAUDMCEF-CWLIKTDRSA-N",
    "display_name": "AMOXICILLIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "263a2902-f85c-46b6-8d5b-8c99f5c4b706": {
      "match": "brand_token",
      "title": "AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70518-2190_4b429aac-3140-b84d-e063-6394a90a991f",
  "productndc": "70518-2190",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "064076",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Sep 30, 1994"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Sep 30, 1994"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN",
  "proprietary_name": "Amoxicillin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA064076",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin",
  "start_marketing_date": "20190709",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01CA04.

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