NDC 50102-100

LYZA

Norethindrone

LYZA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Afaxys Pharma Llc. The primary component is Norethindrone.

• Product ID: 50102-100_230b1884-dd75-444c-a430-624a863a5195
• NDC: 50102-100
• Product Type: Human Prescription Drug
• Proprietary Name: LYZA
• Generic Name: Norethindrone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-06-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200980
• Labeler Name: Afaxys Pharma LLC
• Substance Name: NORETHINDRONE
• Active Ingredient Strength: 0 mg/1
• Pharm Classes: Progesterone Congeners [CS],Progestin [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 50102-100-03

3 PACKAGE in 1 CARTON (50102-100-03) > 1 BLISTER PACK in 1 PACKAGE (50102-100-10) > 28 TABLET in 1 BLISTER PACK (50102-100-00)

• Marketing Start Date: 2017-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50102-100-47 [50102010047]

LYZA TABLET

• Marketing Category: ANDA
• Application Number: ANDA200980
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-06-24
• Marketing End Date: 2013-07-17

NDC 50102-100-00 [50102010000]

LYZA TABLET

• Marketing Category: ANDA
• Application Number: ANDA200980
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-07-17

NDC 50102-100-01 [50102010001]

LYZA TABLET

• Marketing Category: ANDA
• Application Number: ANDA200980
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-07-17

NDC 50102-100-10 [50102010010]

LYZA TABLET

• Marketing Category: ANDA
• Application Number: ANDA200980
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-06-16

NDC 50102-100-03 [50102010003]

LYZA TABLET

• Marketing Category: ANDA
• Application Number: ANDA200980
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-01

NDC 50102-100-48 [50102010048]

LYZA TABLET

• Marketing Category: ANDA
• Application Number: ANDA200980
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-07-18

Drug Details

Active Ingredients

Ingredient	Strength
NORETHINDRONE	.35 mg/1

OpenFDA Data

• SPL SET ID: fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7
• Manufacturer:
  • Afaxys Pharma LLC
• UNII:
  • T18F433X4S
• RxNorm Concept Unique ID - RxCUI:
  • 1430383
  • 198042
  • 748961

Pharmacological Class

• Progesterone Congeners [CS]
• Progestin [EPC]

Medicade Reported Pricing

50102010048 LYZA 0.35 MG TABLET

Pricing Unit: EA | Drug Type:

50102010010 LYZA 0.35 MG TABLET

Pricing Unit: EA | Drug Type:

50102010003 LYZA 0.35 MG TABLET

Pricing Unit: EA | Drug Type:

50102010001 LYZA 0.35 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "LYZA" or generic name "Norethindrone"

NDC	Brand Name	Generic Name
50102-100	LYZA	norethindrone
53002-1687	LYZA	norethindrone
51862-102	Camila	Norethindrone
51862-884	CAMILA	NORETHINDRONE
16714-440	DEBLITANE	Norethindrone
0555-0344	Errin	Norethindrone
51862-100	Errin	Norethindrone
51862-886	ERRIN	NORETHINDRONE
57297-877	Jencycla	norethindrone
52544-892	Jolivette	NORETHINDRONE
50102-300	Lyleq	NORETHINDRONE
53002-1793	Lyleq	NORETHINDRONE
52544-629	Nora BE	Norethindrone
0378-7272	Norethindrone	Norethindrone
0378-7292	NORETHINDRONE	norethindrone
50090-2150	Norethindrone	Norethindrone
50090-6161	NORETHINDRONE	NORETHINDRONE
57297-876	NORETHINDRONE	NORETHINDRONE
63187-748	Norethindrone	Norethindrone
42291-650	Norethindrone Acetate	Norethindrone
50268-602	Norethindrone Acetate	Norethindrone
50090-3235	Norlyda	norethindrone
51660-127	NORLYROC	norethindrone
50458-194	Ortho Micronor	NORETHINDRONE
16714-441	SHAROBEL	Norethindrone
50102-200	Tulana	NORETHINDRONE
53002-2687	Tulana	NORETHINDRONE