Paliperidone

Orange BookUNIISPLATC N05AX13

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN05AX13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4733574483
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-744-83)
ndc11
4733574488
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-744-88)

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": "47335-744_cdd30050-6959-4bea-8830-ed72bde5d4ab",
  "productndc": "47335-744",
  "dosage_form": "TABLET, FILM COATED, 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": "20180801",
  "active_numerator_strength": "1.5"
}

Related drugs

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