NDC 69189-1107

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 Avera Mckennan Hospital. The primary component is Estrogens, Conjugated; Medroxyprogesterone Acetate.

• Product ID: 69189-1107_77384e53-ea65-401b-bcd2-21a32efc889a
• NDC: 69189-1107
• 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: 2016-01-28
• Marketing Category: NDA / NDA
• Application Number: NDA020527
• Labeler Name: Avera McKennan Hospital
• 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: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 69189-1107-1

1 TABLET, SUGAR COATED in 1 DOSE PACK (69189-1107-1)

• Marketing Start Date: 2016-01-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69189-1107-1 [69189110701]

Prempro TABLET, SUGAR COATED

• Marketing Category: NDA
• Application Number: NDA020527
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-01-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ESTROGENS, CONJUGATED	.625 mg/1

OpenFDA Data

• SPL SET ID: 62551977-a89a-4a97-bdf1-ef74868d3c1a
• Manufacturer:
  • Avera McKennan Hospital
• UNII:
  • IU5QR144QX
  • C2QI4IOI2G

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