Prometrium

In shortageOrange BookUNIISPLATC G03DA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAcertis Pharmaceuticals, LLC

CountryUS (United States)

ATC codeG03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7298937230
30 CAPSULE in 1 BOTTLE (72989-372-30)

Annotations

UNII (FDA Substance ID)

4G7DS2Q64Y

PROGESTERONE

RxCUI 8727

Orange Book

N019781

ABAB

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": "ORAL",
  "spl_meta": {
    "1cf237ff-c4f8-4faa-a7aa-77599c856889": {
      "match": "brand_token",
      "title": "PROMETRIUM (PROGESTERONE) CAPSULE [ACERTIS PHARMACEUTICALS, LLC]",
      "spl_version": "3",
      "published_date": "2026-02-26"
    }
  },
  "productid": "72989-372_3d2fed08-88a5-4645-b158-33527a2556eb",
  "productndc": "72989-372",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "019781",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "May 14, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Oct 15, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Oct 15, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROGESTERONE",
  "shortage_reason": "Progesterone Vaginal Gel",
  "shortage_status": "current",
  "proprietary_name": "Prometrium",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019781",
  "marketing_category": "NDA",
  "nonproprietary_name": "Progesterone",
  "start_marketing_date": "20221101",
  "active_numerator_strength": "100"
}

Related drugs

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