premarin

Generic: estrogens, conjugated

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

Drug Facts

Product Profile

Brand Name premarin
Generic Name estrogens, conjugated
Labeler wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

estrogens, conjugated .625 mg/1

Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Identifiers & Regulatory

Product NDC 0046-1102
Product ID 0046-1102_7273b788-92aa-4d38-8812-33edaf21bd42
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA004782
Listing Expiration 2027-12-31
Marketing Start 2006-01-01

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 00461102
Hyphenated Format 0046-1102

Supplemental Identifiers

RxCUI
150840 197660 197661 197662 202301 208513 208949 310197 403849 404550
UPC
0300461103815 0300461101811
UNII
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 premarin (source: ndc)
Generic Name estrogens, conjugated (source: ndc)
Application Number NDA004782 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .625 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0046-1102-52) / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • 100 TABLET, FILM COATED in 1 BOTTLE (0046-1102-81)
  • 1 BOTTLE in 1 CARTON (0046-1102-91) / 1000 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

0046-1102-52 1 BLISTER PACK in 1 CARTON (0046-1102-52) / 5 TABLET, FILM COATED in 1 BLISTER PACK 0046-1102-81 100 TABLET, FILM COATED in 1 BOTTLE (0046-1102-81) 0046-1102-91 1 BOTTLE in 1 CARTON (0046-1102-91) / 1000 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

estrogens, conjugated (.625 mg/1)

Linked Drug Pages (1)

Premarin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7273b788-92aa-4d38-8812-33edaf21bd42", "openfda": {"nui": ["N0000175825", "N0000000100", "M0007792"], "upc": ["0300461103815", "0300461101811"], "unii": ["IU5QR144QX"], "rxcui": ["150840", "197660", "197661", "197662", "202301", "208513", "208949", "310197", "403849", "404550"], "spl_set_id": ["258e1602-a3cf-4ccc-ca80-73dbbfb812ff"], "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 (0046-1102-52)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0046-1102-52", "marketing_start_date": "20200210"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0046-1102-81)", "package_ndc": "0046-1102-81", "marketing_start_date": "20060101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0046-1102-91)  / 1000 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0046-1102-91", "marketing_start_date": "20060101"}], "brand_name": "Premarin", "product_id": "0046-1102_7273b788-92aa-4d38-8812-33edaf21bd42", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Estrogens", "Conjugated (USP) [CS]"], "product_ndc": "0046-1102", "generic_name": "estrogens, conjugated", "labeler_name": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Premarin", "active_ingredients": [{"name": "ESTROGENS, CONJUGATED", "strength": ".625 mg/1"}], "application_number": "NDA004782", "marketing_category": "NDA", "marketing_start_date": "20060101", "listing_expiration_date": "20271231"}