NDC 68258-5978

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 Dispensing Solutions, Inc.. The primary component is Estrogens, Conjugated; Medroxyprogesterone Acetate.

• Product ID: 68258-5978_cb3ae439-62fe-48c7-94de-a6e5f518a973
• NDC: 68258-5978
• 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: 2009-09-21
• Marketing Category: NDA / NDA
• Application Number: NDA020527
• Labeler Name: Dispensing Solutions, Inc.
• Substance Name: ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
• Active Ingredient Strength: 0 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: 2017-12-31

Packaging

NDC 68258-5978-2

1 BLISTER PACK in 1 CARTON (68258-5978-2) > 28 TABLET, SUGAR COATED in 1 BLISTER PACK

• Marketing Start Date: 2009-09-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68258-5978-2 [68258597802]

Prempro TABLET, SUGAR COATED

• Marketing Category: NDA
• Application Number: NDA020527
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-09-21
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
ESTROGENS, CONJUGATED	.3 mg/1

OpenFDA Data

• SPL SET ID: 198d547d-c985-46bc-a66f-e3182a294cb5
• Manufacturer:
  • Dispensing Solutions, Inc.
• UNII:
  • IU5QR144QX
  • C2QI4IOI2G
• RxNorm Concept Unique ID - RxCUI:
  • 1000355
  • 1000395
  • 1000491
  • 1000490
  • 1000351
  • 1000499

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