PANTOPRAZOLE SODIUM

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeA02BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7161065330
30 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-30)
ndc11
7161065353
60 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-53)
ndc11
7161065360
90 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-60)
ndc11
7161065380
180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-80)

Annotations

UNII (FDA Substance ID)

6871619Q5X

PANTOPRAZOLE SODIUM

RxCUI 236632

Orange Book

A202882

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6871619Q5X",
    "rxcui": "236632",
    "inchikey": "VNKNFEINTHUQGZ-UHFFFAOYSA-N",
    "display_name": "PANTOPRAZOLE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52bbab54-9f11-77bc-e063-6394a90ab449": {
      "match": "brand_token",
      "title": "PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "71610-653_6c0bca16-d681-48d1-a07a-93d9d0f3acef",
  "productndc": "71610-653",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "202882",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Sep 10, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Sep 10, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PANTOPRAZOLE SODIUM",
  "proprietary_name": "PANTOPRAZOLE SODIUM",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202882",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PANTOPRAZOLE",
  "start_marketing_date": "20220501",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code A02BC02.

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