NDC 0046-1108

Prempro

Conjugated Estrogens And Medroxyprogesterone Acetate

Prempro is a Oral Tablet, Sugar Coated in the Human Prescription Drug category. It is labeled and distributed by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The primary component is Estrogens, Conjugated; Medroxyprogesterone Acetate.

• Product ID: 0046-1108_1a258b22-1b1b-48af-912f-bc895ea32ada
• NDC: 0046-1108
• Product Type: Human Prescription Drug
• Proprietary Name: Prempro
• Generic Name: Conjugated Estrogens And Medroxyprogesterone Acetate
• Dosage Form: Tablet, Sugar Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-12-03
• Marketing Category: NDA / NDA
• Application Number: NDA020527
• Labeler Name: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• Substance Name: ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
• Active Ingredient Strength: 1 mg/1; mg/1
• Pharm Classes: Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS],Progesterone Congeners [CS],Progestin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0046-1108-11

1 BLISTER PACK in 1 CARTON (0046-1108-11) > 28 TABLET, SUGAR COATED in 1 BLISTER PACK

• Marketing Start Date: 2012-12-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0046-1108-11 [00046110811]

Prempro TABLET, SUGAR COATED

• Marketing Category: NDA
• Application Number: NDA020527
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-12-03

Drug Details

Active Ingredients

Ingredient	Strength
ESTROGENS, CONJUGATED	.625 mg/1

OpenFDA Data

• SPL SET ID: fd0c0836-5d23-2183-da81-9dc7f4287052
• Manufacturer:
  • Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• UNII:
  • IU5QR144QX
  • C2QI4IOI2G
• RxNorm Concept Unique ID - RxCUI:
  • 1000398
  • 1000500
  • 1000356
  • 1000499
  • 1000355
  • 1000352
  • 1000351
  • 1000497
  • 1000496
  • 1000486
  • 1000487
  • 310197
  • 1000491
  • 1000395
  • 150840
  • 1000490

Pharmacological Class

• Estrogen [EPC]
• Estrogen Receptor Agonists [MoA]
• Estrogens
• Conjugated (USP) [CS]
• Progesterone Congeners [CS]
• Progestin [EPC]

NDC Crossover Matching brand name "Prempro" or generic name "Conjugated Estrogens And Medroxyprogesterone Acetate"

NDC	Brand Name	Generic Name
0046-1105	Prempro	conjugated estrogens and medroxyprogesterone acetate
0046-1106	Prempro	conjugated estrogens and medroxyprogesterone acetate
0046-1107	Prempro	conjugated estrogens and medroxyprogesterone acetate
0046-1108	Prempro	conjugated estrogens and medroxyprogesterone acetate
50090-0573	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE
68258-5978	Prempro	conjugated estrogens and medroxyprogesterone acetate
68258-5980	Prempro	conjugated estrogens and medroxyprogesterone acetate
69189-1107	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE
0046-2575	Premphase	conjugated estrogens and medroxyprogesterone acetate