Premphase

Orange BookSPL

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

Identification

ManufacturerWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0046257512
1 BLISTER PACK in 1 CARTON (0046-2575-12) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N020527

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "fd0c0836-5d23-2183-da81-9dc7f4287052": {
      "match": "brand_token",
      "title": "PREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]",
      "spl_version": "39",
      "published_date": "2026-04-29"
    }
  },
  "productid": "0046-2575_cce04608-5f9f-434f-b4ab-d5c19847095a",
  "productndc": "0046-2575",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "020527",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.625MG;2.5MG",
        "product_no": "001",
        "approval_date": "Nov 17, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.625MG,0.625MG;N/A,5MG",
        "product_no": "002",
        "approval_date": "Nov 17, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.625MG;5MG",
        "product_no": "003",
        "approval_date": "Jan 9, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.45MG;1.5MG",
        "product_no": "004",
        "approval_date": "Mar 12, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.3MG;1.5MG",
        "product_no": "005",
        "approval_date": "Jun 4, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Premphase",
  "active_ingred_unit": null,
  "application_number": "NDA020527",
  "marketing_category": "NDA",
  "nonproprietary_name": "conjugated estrogens and medroxyprogesterone acetate",
  "start_marketing_date": "20120301",
  "active_numerator_strength": null
}

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