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United States · US · US:51862-884_022c6de4-4589-4d4c-8ac4-977c7e3ef568

CAMILA

Orange BookUNIISPLATC G03DC02

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

Identification

ManufacturerMayne Pharma Inc.
CountryUS (United States)
ATC codeG03DC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5186288403
    3 BLISTER PACK in 1 CARTON (51862-884-03) / 28 TABLET in 1 BLISTER PACK (51862-884-01)

Annotations

UNII (FDA Substance ID)
T18F433X4S
NORETHINDRONE
RxCUI 7514
Orange Book
A076177
AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "T18F433X4S",
    "rxcui": "7514",
    "inchikey": "VIKNJXKGJWUCNN-XGXHKTLJSA-N",
    "display_name": "NORETHINDRONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "59985565-af09-21ba-0336-3f6db7711bd1": {
      "match": "brand_token",
      "title": "CAMILA (NORETHINDRONE) TABLET [DR. REDDY'S LABRATORIES INC.]",
      "spl_version": "1",
      "published_date": "2024-05-07"
    }
  },
  "productid": "51862-884_022c6de4-4589-4d4c-8ac4-977c7e3ef568",
  "productndc": "51862-884",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076177",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.35MG",
        "product_no": "001",
        "approval_date": "Oct 21, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NORETHINDRONE",
  "proprietary_name": "CAMILA",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076177",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NORETHINDRONE",
  "start_marketing_date": "20180615",
  "active_numerator_strength": ".35"
}

Related drugs

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