Paliperidone

Orange BookUNIISPLATC N05AX13

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeN05AX13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7051842670
30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4267-0)
ndc11
7051842671
30 POUCH in 1 BOX (70518-4267-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4267-2)

Annotations

UNII (FDA Substance ID)

838F01T721

PALIPERIDONE

RxCUI 679314

Orange Book

A205618

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "838F01T721",
    "rxcui": "679314",
    "inchikey": "PMXMIIMHBWHSKN-UHFFFAOYSA-N",
    "display_name": "PALIPERIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f75e884e-1883-45d7-ac9b-4a6c63f2185e": {
      "match": "brand_token",
      "title": "PALIPERIDONE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "100",
      "published_date": "2026-05-28"
    }
  },
  "productid": "70518-4267_400ab61f-5daf-6925-e063-6394a90ae1f6",
  "productndc": "70518-4267",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205618",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "Apr 6, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "002",
        "approval_date": "Apr 6, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "003",
        "approval_date": "Apr 6, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "9MG",
        "product_no": "004",
        "approval_date": "Apr 6, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALIPERIDONE",
  "proprietary_name": "Paliperidone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205618",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Paliperidone",
  "start_marketing_date": "20250127",
  "active_numerator_strength": "9"
}

Related drugs

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