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United States · US · US:71335-9713_9a404143-c284-41e8-a20b-f399a87f658e

esomeprazole magnesium

Orange BookSPLATC A02BC05

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA02BC05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    7133597131
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-1)
  • ndc11
    7133597132
    10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-2)
  • ndc11
    7133597133
    60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-3)
  • ndc11
    7133597134
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-4)
  • ndc11
    7133597135
    42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-5)
  • ndc11
    7133597136
    120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-6)
  • ndc11
    7133597137
    180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-7)
  • ndc11
    7133597138
    20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-8)

Annotations

Orange Book
A213486
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "6a21f085-b60b-49b7-8098-99ccdc43dde3": {
      "match": "brand_token",
      "title": "ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG (OTC) CAPSULE, DELAYED RELEASE ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE 20 MG MINI CAPSULE, DELAYED RELEASE [MARKSANS PHARMA LIMITED]",
      "spl_version": "3",
      "published_date": "2026-06-02"
    }
  },
  "productid": "71335-9713_9a404143-c284-41e8-a20b-f399a87f658e",
  "productndc": "71335-9713",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "213486",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Mar 19, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Mar 19, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESOMEPRAZOLE MAGNESIUM",
  "proprietary_name": "esomeprazole magnesium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213486",
  "marketing_category": "ANDA",
  "nonproprietary_name": "esomeprazole magnesium",
  "start_marketing_date": "20210319",
  "active_numerator_strength": "20"
}

Related drugs

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