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United States · US · US:0054-0106_4019e596-dfb9-43a4-b027-a2bdf6d0f5b4

Ramipril

Orange BookUNIISPLATC C09AA05

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC09AA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0054010625
    100 CAPSULE in 1 BOTTLE (0054-0106-25)

Annotations

UNII (FDA Substance ID)
L35JN3I7SJ
RAMIPRIL
RxCUI 35296
Orange Book
A077900
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "L35JN3I7SJ",
    "rxcui": "35296",
    "inchikey": "HDACQVRGBOVJII-JBDAPHQKSA-N",
    "display_name": "RAMIPRIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a8cdec12-81d1-4ef4-82c0-d05d93c37a07": {
      "match": "brand_token",
      "title": "RAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "19",
      "published_date": "2026-05-29"
    }
  },
  "productid": "0054-0106_4019e596-dfb9-43a4-b027-a2bdf6d0f5b4",
  "productndc": "0054-0106",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077900",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.25MG",
        "product_no": "001",
        "approval_date": "Jun 18, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "Jun 18, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Jun 18, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Jun 18, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RAMIPRIL",
  "proprietary_name": "Ramipril",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077900",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ramipril",
  "start_marketing_date": "20080618",
  "active_numerator_strength": "1.25"
}

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