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United States · US · US:43598-307_dc9f1708-68a6-cb89-36c5-4e5fdb30100e

Omeprazole and Sodium Bicarbonate

Orange BookUNIISPLATC A02BC

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.,
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    4359830701
    1 PACKET in 1 CARTON (43598-307-01) / 1 POWDER, FOR SUSPENSION in 1 PACKET
  • ndc11
    4359830714
    14 PACKET in 1 CARTON (43598-307-14) / 1 POWDER, FOR SUSPENSION in 1 PACKET
  • ndc11
    4359830728
    28 PACKET in 1 CARTON (43598-307-28) / 1 POWDER, FOR SUSPENSION in 1 PACKET
  • ndc11
    4359830742
    42 PACKET in 1 CARTON (43598-307-42) / 1 POWDER, FOR SUSPENSION in 1 PACKET

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A217784
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": {
    "b3ec4a44-5643-4438-b41b-e04946436719": {
      "match": "brand_token",
      "title": "OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY]",
      "spl_version": "3",
      "published_date": "2026-05-29"
    }
  },
  "productid": "43598-307_dc9f1708-68a6-cb89-36c5-4e5fdb30100e",
  "productndc": "43598-307",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "217784",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/PACKET;1.68GM/PACKET",
        "product_no": "001",
        "approval_date": "May 9, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OMEPRAZOLE; SODIUM BICARBONATE",
  "proprietary_name": "Omeprazole and Sodium Bicarbonate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA217784",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole and Sodium Bicarbonate",
  "start_marketing_date": "20240715",
  "active_numerator_strength": "20; 1680"
}

Related drugs

Other records sharing ATC code A02BC.

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