NDC 69238-1251

Lopreeza

Estradiol/norethindrone Acetate

Lopreeza is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Estradiol; Norethindrone Acetate.

• Product ID: 69238-1251_1ced7000-e6a5-489c-9243-fc568e9887e3
• NDC: 69238-1251
• Product Type: Human Prescription Drug
• Proprietary Name: Lopreeza
• Generic Name: Estradiol/norethindrone Acetate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-10-01
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA020907
• Labeler Name: Amneal Pharmaceuticals NY LLC
• Substance Name: ESTRADIOL; NORETHINDRONE ACETATE
• Active Ingredient Strength: 1 mg/1; mg/1
• Pharm Classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [CS],Progestin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 69238-1251-8

5 CARTON in 1 CELLO PACK (69238-1251-8) > 1 DIALPACK in 1 CARTON (69238-1251-6) > 28 TABLET, FILM COATED in 1 DIALPACK

• Marketing Start Date: 2014-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69238-1251-6 [69238125106]

Lopreeza TABLET, FILM COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA020907
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-01

NDC 69238-1251-8 [69238125108]

Lopreeza TABLET, FILM COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA020907
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-01

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	1 mg/1

OpenFDA Data

• SPL SET ID: bf0e39cb-95e7-4831-92d2-0b3f071aeaae
• Manufacturer:
  • Amneal Pharmaceuticals LLC
• UNII:
  • 9S44LIC7OJ
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 1359126
  • 1359127
  • 1359124
  • 1359123
  • 1550965
  • 1550964
• UPC Code:
  • 0369238125269
  • 0369238125160

Pharmacological Class

• Estradiol Congeners [CS]
• Estrogen [EPC]
• Estrogen Receptor Agonists [MoA]
• Progesterone Congeners [CS]
• Progestin [EPC]

Medicade Reported Pricing

69238125108 LOPREEZA 1 MG-0.5 MG TABLET

Pricing Unit: EA | Drug Type:

69238125106 LOPREEZA 1 MG-0.5 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Lopreeza" or generic name "Estradiol/norethindrone Acetate"

NDC	Brand Name	Generic Name
69238-1251	Lopreeza	estradiol/norethindrone acetate
69238-1252	Lopreeza	estradiol/norethindrone acetate
69238-1609	LOPREEZA	estradiol/norethindrone acetate
69238-1610	LOPREEZA	estradiol/norethindrone acetate
60846-231	Activella	Estradiol/norethindrone acetate
60846-232	Activella	Estradiol/norethindrone acetate