NDC 53002-1687

LYZA

Norethindrone

LYZA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Norethindrone.

• Product ID: 53002-1687_19ac3421-1296-4bf7-afea-de4771da9bb4
• NDC: 53002-1687
• 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: RPK Pharmaceuticals, Inc.
• Substance Name: NORETHINDRONE
• Active Ingredient Strength: 0 mg/1
• Pharm Classes: Progesterone Congeners [CS],Progestin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53002-1687-1

28 TABLET in 1 POUCH (53002-1687-1)

• Marketing Start Date: 2017-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53002-1687-1 [53002168701]

LYZA TABLET

• Marketing Category: ANDA
• Application Number: ANDA200980
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-01
• Inactivation Date: 2020-01-31

NDC 53002-1687-3 [53002168703]

LYZA TABLET

• Marketing Category: ANDA
• Application Number: ANDA200980
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-01
• Inactivation Date: 2020-01-31

NDC 53002-1687-6 [53002168706]

LYZA TABLET

• Marketing Category: ANDA
• Application Number: ANDA200980
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
NORETHINDRONE	.35 mg/1

OpenFDA Data

• SPL SET ID: 5ce0eb18-6e34-4ec0-982b-2bddac311404
• Manufacturer:
  • RPK Pharmaceuticals, Inc.
• UNII:
  • T18F433X4S
• RxNorm Concept Unique ID - RxCUI:
  • 1430383
  • 198042
  • 748961

Pharmacological Class

• Progesterone Congeners [CS]
• Progestin [EPC]

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