NDC 60846-231

Activella

Estradiol/norethindrone Acetate

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

• Product ID: 60846-231_5be257d4-9989-4b95-8155-b92d77a74836
• NDC: 60846-231
• Product Type: Human Prescription Drug
• Proprietary Name: Activella
• Generic Name: Estradiol/norethindrone Acetate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA020907
• Labeler Name: Amneal Pharmaceuticals 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: 2022-12-31

Packaging

NDC 60846-231-01

1 BLISTER PACK in 1 CARTON (60846-231-01) > 28 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2019-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60846-231-01 [60846023101]

Activella TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020907
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-01

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	.5 mg/1

OpenFDA Data

• SPL SET ID: d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0
• Manufacturer:
  • Gemini Laboratories, LLC
• UNII:
  • 9S44LIC7OJ
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 1359126
  • 1359127
  • 1359124
  • 1359125
  • 1359123
  • 1359128
• UPC Code:
  • 0360846232011
  • 0360846231014

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
60846-201	Activella	estradiol and norethindrone acetate
60846-202	Activella	estradiol and norethindrone acetate
60846-231	Activella	Estradiol/norethindrone acetate
60846-232	Activella	Estradiol/norethindrone acetate
69238-1251	Lopreeza	estradiol/norethindrone acetate
69238-1252	Lopreeza	estradiol/norethindrone acetate
69238-1609	LOPREEZA	estradiol/norethindrone acetate
69238-1610	LOPREEZA	estradiol/norethindrone acetate