Pantoprazole

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerDr.Reddy's Laboratories Limited

CountryUS (United States)

ATC codeA02BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
5511133301
100 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-333-01)
ndc11
5511133305
500 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-333-05)
ndc11
5511133310
1000 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-333-10)
ndc11
5511133330
30 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-333-30)
ndc11
5511133378
10 BLISTER PACK in 1 CARTON (55111-333-78) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-333-79)
ndc11
5511133381
3 BLISTER PACK in 1 CARTON (55111-333-81) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-333-79)
ndc11
5511133390
90 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-333-90)

Annotations

UNII (FDA Substance ID)

6871619Q5X

PANTOPRAZOLE SODIUM

RxCUI 236632

Orange Book

A077619

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": "55111-333_c0575fc6-20c4-12a6-10b7-1af65cac1ee0",
  "productndc": "55111-333",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "077619",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jan 19, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Jan 19, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PANTOPRAZOLE SODIUM",
  "proprietary_name": "Pantoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077619",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pantoprazole",
  "start_marketing_date": "20110119",
  "active_numerator_strength": "40"
}

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