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United States · US · US:65841-658_1d7227b2-6052-40b4-bf22-29f18672ce08

Ramipril

Orange BookUNIISPLATC C09AA05

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeC09AA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6584165801
    100 CAPSULE in 1 BOTTLE (65841-658-01)
  • ndc11
    6584165805
    500 CAPSULE in 1 BOTTLE (65841-658-05)
  • ndc11
    6584165806
    30 CAPSULE in 1 BOTTLE (65841-658-06)
  • ndc11
    6584165816
    90 CAPSULE in 1 BOTTLE (65841-658-16)
  • ndc11
    6584165830
    10 BLISTER PACK in 1 CARTON (65841-658-30) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
L35JN3I7SJ
RAMIPRIL
RxCUI 35296
Orange Book
A078832
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": "65841-658_1d7227b2-6052-40b4-bf22-29f18672ce08",
  "productndc": "65841-658",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "078832",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.25MG",
        "product_no": "001",
        "approval_date": "Sep 2, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "Sep 2, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Sep 2, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Sep 2, 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": "ANDA078832",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ramipril",
  "start_marketing_date": "20101120",
  "active_numerator_strength": "10"
}

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