premphase

Generic: conjugated estrogens and medroxyprogesterone acetate

Labeler: wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name premphase
Generic Name conjugated estrogens and medroxyprogesterone acetate
Labeler wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
Dosage Form KIT
Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Identifiers & Regulatory

Product NDC 0046-2575
Product ID 0046-2575_28de5402-2ae3-4da8-a9ed-b6c4a798c8bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020527
Listing Expiration 2026-12-31
Marketing Start 2012-03-01

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estrogens, conjugated (usp) [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00462575
Hyphenated Format 0046-2575

Supplemental Identifiers

RxCUI
150840 310197 1000351 1000352 1000355 1000356 1000395 1000398 1000486 1000487 1000490 1000491 1000496 1000497 1000499 1000500
UNII
C2QI4IOI2G IU5QR144QX
NUI
N0000175825 N0000000100 M0007792

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name premphase (source: ndc)
Generic Name conjugated estrogens and medroxyprogesterone acetate (source: ndc)
Application Number NDA020527 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 0.3 mg
  • 1.5 mg
  • 0.45 mg
  • 0.625 mg
  • 2.5 mg
  • 5 mg
  • 0.3 mg/1.5 mg
  • 0.45 mg/1.5 mg
  • 0.625 mg/2.5 mg
  • 0.625 mg/5 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 CARTON (0046-2575-12) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

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

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Prempro, Premphase ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "28de5402-2ae3-4da8-a9ed-b6c4a798c8bd", "openfda": {"nui": ["N0000175825", "N0000000100", "M0007792"], "unii": ["C2QI4IOI2G", "IU5QR144QX"], "rxcui": ["150840", "310197", "1000351", "1000352", "1000355", "1000356", "1000395", "1000398", "1000486", "1000487", "1000490", "1000491", "1000496", "1000497", "1000499", "1000500"], "spl_set_id": ["fd0c0836-5d23-2183-da81-9dc7f4287052"], "pharm_class_cs": ["Estrogens, Conjugated (USP) [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0046-2575-12)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0046-2575-12", "marketing_start_date": "20120301"}], "brand_name": "Premphase", "product_id": "0046-2575_28de5402-2ae3-4da8-a9ed-b6c4a798c8bd", "dosage_form": "KIT", "product_ndc": "0046-2575", "generic_name": "conjugated estrogens and medroxyprogesterone acetate", "labeler_name": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Premphase", "application_number": "NDA020527", "marketing_category": "NDA", "marketing_start_date": "20120301", "listing_expiration_date": "20261231"}