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United States · US · US:59651-136_b785dba5-f0b0-4f74-8845-e845432932c0

Emzahh

Orange BookUNIIATC G03DC02

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

Identification

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

Packs · 3

  • ndc11
    5965113628
    1 BLISTER PACK in 1 CARTON (59651-136-28) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    5965113688
    3 POUCH in 1 CARTON (59651-136-88) / 1 TABLET in 1 POUCH
  • ndc11
    5965113692
    6 POUCH in 1 CARTON (59651-136-92) / 1 TABLET in 1 POUCH

Annotations

UNII (FDA Substance ID)
T18F433X4S
NORETHINDRONE
RxCUI 7514
Orange Book
A216796
AB2
Raw payload (JSON)
{
  "unii": {
    "unii": "T18F433X4S",
    "rxcui": "7514",
    "inchikey": "VIKNJXKGJWUCNN-XGXHKTLJSA-N",
    "display_name": "NORETHINDRONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "59651-136_b785dba5-f0b0-4f74-8845-e845432932c0",
  "productndc": "59651-136",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216796",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "0.35MG",
        "product_no": "001",
        "approval_date": "Jan 6, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NORETHINDRONE",
  "proprietary_name": "Emzahh",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216796",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NORETHINDRONE",
  "start_marketing_date": "20230106",
  "active_numerator_strength": ".35"
}

Related drugs

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