ziprasidone

Orange BookUNIISPLATC N05AE04

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

Identification

ManufacturerDr. Reddy's Laboratories Limited

CountryUS (United States)

ATC codeN05AE04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
5511125601
100 CAPSULE in 1 BOTTLE (55111-256-01)
ndc11
5511125605
500 CAPSULE in 1 BOTTLE (55111-256-05)
ndc11
5511125630
30 CAPSULE in 1 BOTTLE (55111-256-30)
ndc11
5511125660
60 CAPSULE in 1 BOTTLE (55111-256-60)
ndc11
5511125678
10 BLISTER PACK in 1 CARTON (55111-256-78) / 10 CAPSULE in 1 BLISTER PACK
ndc11
5511125681
3 BLISTER PACK in 1 CARTON (55111-256-81) / 10 CAPSULE in 1 BLISTER PACK
ndc11
5511125690
90 CAPSULE in 1 BOTTLE (55111-256-90)

Annotations

UNII (FDA Substance ID)

216X081ORU

ZIPRASIDONE HYDROCHLORIDE

RxCUI 284925

Orange Book

A077565

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "216X081ORU",
    "rxcui": "284925",
    "inchikey": "ZCBZSCBNOOIHFP-UHFFFAOYSA-N",
    "display_name": "ZIPRASIDONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7e7261d7-4902-4bb5-a268-6c358890f963": {
      "match": "brand_token",
      "title": "ZIPRASIDONE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]",
      "spl_version": "18",
      "published_date": "2026-05-25"
    }
  },
  "productid": "55111-256_7eaaea2d-4068-4a22-c7f5-c4ac01d418a1",
  "productndc": "55111-256",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077565",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Mar 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Mar 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Mar 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Mar 2, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZIPRASIDONE HYDROCHLORIDE",
  "proprietary_name": "ziprasidone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077565",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ziprasidone",
  "start_marketing_date": "20120302",
  "active_numerator_strength": "20"
}

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