NDC 52544-295

Amethyst

Levonorgestrel And Ethinyl Estradiol

Amethyst is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Levonorgestrel; Ethinyl Estradiol.

• Product ID: 52544-295_2f24c2e9-ed26-42ff-b284-92c63645c389
• NDC: 52544-295
• Product Type: Human Prescription Drug
• Proprietary Name: Amethyst
• Generic Name: Levonorgestrel And Ethinyl Estradiol
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2011-06-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079218
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: LEVONORGESTREL; ETHINYL ESTRADIOL
• Active Ingredient Strength: 90 ug/1; ug/1
• Pharm Classes: Inhibit Ovum Fertilization [PE],Progesterone Congeners [CS],Progesterone Congeners [CS],Progestin [EPC],Progestin-containing Intrauterine Device [EPC],Estrogen Receptor Agonists [MoA],Estrogen [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52544-295-28

1 POUCH in 1 CARTON (52544-295-28) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2011-06-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52544-295-28 [52544029528]

Amethyst TABLET

• Marketing Category: ANDA
• Application Number: ANDA079218
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-06-13

Drug Details

Active Ingredients

Ingredient	Strength
LEVONORGESTREL	90 ug/1

OpenFDA Data

• SPL SET ID: a7e19182-57b5-4783-9c7f-bb83961f1803
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • 423D2T571U
  • 5W7SIA7YZW
• RxNorm Concept Unique ID - RxCUI:
  • 751553
  • 1112715
  • 722152
• UPC Code:
  • 0352544295283

Pharmacological Class

• Inhibit Ovum Fertilization [PE]
• Progesterone Congeners [CS]
• Progesterone Congeners [CS]
• Progestin [EPC]
• Progestin-containing Intrauterine Device [EPC]
• Estrogen Receptor Agonists [MoA]
• Estrogen [EPC]

Medicade Reported Pricing

52544029528 AMETHYST 90-20 MCG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Amethyst" or generic name "Levonorgestrel And Ethinyl Estradiol"

NDC	Brand Name	Generic Name
0480-3472	Amethyst	Levonorgestrel and Ethinyl Estradiol
52544-295	Amethyst	Amethyst
0555-9045	Aviane	Levonorgestrel and Ethinyl Estradiol
0555-9047	Enpresse	Levonorgestrel and Ethinyl Estradiol
0555-9014	Lessina	Levonorgestrel and Ethinyl Estradiol
0378-6550	LEVONORGESTREL AND ETHINYL ESTRADIOL	levonorgestrel and ethinyl estradiol
0378-7281	LEVONORGESTREL AND ETHINYL ESTRADIOL	Levonorgestrel and Ethinyl Estradiol
0378-7287	LEVONORGESTREL AND ETHINYL ESTRADIOL	Levonorgestrel and Ethinyl Estradiol
0378-7298	LEVONORGESTREL AND ETHINYL ESTRADIOL	levonorgestrel and ethinyl estradiol
0591-0295	Levonorgestrel and Ethinyl Estradiol	Levonorgestrel and Ethinyl Estradiol
0642-7471	Levonorgestrel and Ethinyl Estradiol	Levonorgestrel and Ethinyl Estradiol
0603-7625	Myzilra	Levonorgestrel and Ethinyl Estradiol
0254-2032	Orsythia	Levonorgestrel and Ethinyl Estradiol
0603-7634	Orsythia	levonorgestrel and ethinyl estradiol
0555-9020	Portia	Levonorgestrel and Ethinyl Estradiol
0781-5575	Vienva TM	Levonorgestrel and Ethinyl Estradiol