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United States · US · US:71205-985_adaa81e9-047d-486e-aa53-d6cb4e931220

Omeprazole/Bicarbonate

Orange BookUNIISPLATC A02BC

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7120598530
    30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (71205-985-30)
  • ndc11
    7120598560
    60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (71205-985-60)
  • ndc11
    7120598590
    90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (71205-985-90)

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A207476
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "KG60484QX9",
    "rxcui": "7646",
    "inchikey": "SUBDBMMJDZJVOS-UHFFFAOYSA-N",
    "display_name": "OMEPRAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4d642036-7175-4f29-9f07-dbd282231d4a": {
      "match": "brand_token",
      "title": "OMEPRAZOLE/BICARBONATE (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE, GELATIN COATED [PROFICIENT RX LP]",
      "spl_version": "3",
      "published_date": "2026-04-29"
    }
  },
  "productid": "71205-985_adaa81e9-047d-486e-aa53-d6cb4e931220",
  "productndc": "71205-985",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "207476",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG;1.1GM",
        "product_no": "001",
        "approval_date": "Dec 6, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG;1.1GM",
        "product_no": "002",
        "approval_date": "Dec 6, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OMEPRAZOLE; SODIUM BICARBONATE",
  "proprietary_name": "Omeprazole/Bicarbonate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207476",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole and Sodium Bicarbonate",
  "start_marketing_date": "20180727",
  "active_numerator_strength": "40; 1100"
}

Related drugs

Other records sharing ATC code A02BC.

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