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United States · US · US:70095-136_5232dd12-1767-7fa2-e063-6294a90a4e70

PROGESTERONE

In shortageOrange BookUNIISPLATC G03DA04

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeG03DA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7009513603
    1 CARTON in 1 CARTON (70095-136-03) / 21 BLISTER PACK in 1 CARTON (70095-136-02) / 1 INSERT in 1 BLISTER PACK (70095-136-01)

Annotations

UNII (FDA Substance ID)
4G7DS2Q64Y
PROGESTERONE
RxCUI 8727
Orange Book
N022057
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Progesterone Vaginal Gel
Raw payload (JSON)
{
  "unii": {
    "unii": "4G7DS2Q64Y",
    "rxcui": "8727",
    "inchikey": "RJKFOVLPORLFTN-LEKSSAKUSA-N",
    "display_name": "PROGESTERONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "41b3c3a7-5fb8-4451-a96c-2bd02613c021": {
      "match": "brand_token",
      "title": "PROGESTERONE CAPSULE [BIONPHARMA INC.]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70095-136_5232dd12-1767-7fa2-e063-6294a90a4e70",
  "productndc": "70095-136",
  "dosage_form": "INSERT",
  "orange_book": {
    "appl_no": "022057",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jun 21, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROGESTERONE",
  "shortage_reason": "Progesterone Vaginal Gel",
  "shortage_status": "current",
  "proprietary_name": "PROGESTERONE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022057",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Progesterone",
  "start_marketing_date": "20260427",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code G03DA04.

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