prempro

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 prempro
Generic Name conjugated estrogens and medroxyprogesterone acetate
Labeler wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
Dosage Form TABLET, SUGAR COATED
Routes
ORAL
Active Ingredients

estrogens, conjugated .45 mg/1, medroxyprogesterone acetate 1.5 mg/1

Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Identifiers & Regulatory

Product NDC 0046-1106
Product ID 0046-1106_28de5402-2ae3-4da8-a9ed-b6c4a798c8bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020527
Listing Expiration 2026-12-31
Marketing Start 2009-09-21

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 00461106
Hyphenated Format 0046-1106

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 prempro (source: ndc)
Generic Name conjugated estrogens and medroxyprogesterone acetate (source: ndc)
Application Number NDA020527 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .45 mg/1
  • 1.5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0046-1106-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0046-1106-11 1 BLISTER PACK in 1 CARTON (0046-1106-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK

Ingredients (2)

estrogens, conjugated (.45 mg/1) medroxyprogesterone acetate (1.5 mg/1)

Linked Drug Pages (1)

Prempro, Premphase ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "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 (0046-1106-11)  / 28 TABLET, SUGAR COATED in 1 BLISTER PACK", "package_ndc": "0046-1106-11", "marketing_start_date": "20090921"}], "brand_name": "Prempro", "product_id": "0046-1106_28de5402-2ae3-4da8-a9ed-b6c4a798c8bd", "dosage_form": "TABLET, SUGAR COATED", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Estrogens", "Conjugated (USP) [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0046-1106", "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": "Prempro", "active_ingredients": [{"name": "ESTROGENS, CONJUGATED", "strength": ".45 mg/1"}, {"name": "MEDROXYPROGESTERONE ACETATE", "strength": "1.5 mg/1"}], "application_number": "NDA020527", "marketing_category": "NDA", "marketing_start_date": "20090921", "listing_expiration_date": "20261231"}