NDC 43393-001

Mifepristone

Mifepristone

Mifepristone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Genbiopro, Inc.. The primary component is Mifepristone.

• Product ID: 43393-001_a70938c4-34a6-0dfc-e053-2a95a90a2fe3
• NDC: 43393-001
• Product Type: Human Prescription Drug
• Proprietary Name: Mifepristone
• Generic Name: Mifepristone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091178
• Labeler Name: GenBioPro, Inc.
• Substance Name: MIFEPRISTONE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Progestational Hormone Receptor Antagonists [MoA],Progestin Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 43393-001-06

6 CARTON in 1 PACKAGE (43393-001-06) > 1 BLISTER PACK in 1 CARTON > 1 TABLET in 1 BLISTER PACK (43393-001-01)

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

NDC SPL Data Element Entries

NDC 43393-001-06 [43393000106]

Mifepristone TABLET

• Marketing Category: ANDA
• Application Number: ANDA091178
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-01

NDC 43393-001-01 [43393000101]

Mifepristone TABLET

• Marketing Category: ANDA
• Application Number: ANDA091178
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-01

Drug Details

Active Ingredients

Ingredient	Strength
MIFEPRISTONE	200 mg/1

Pharmacological Class

• Progestational Hormone Receptor Antagonists [MoA]
• Progestin Antagonist [EPC]
• Progestational Hormone Receptor Antagonists [MoA]
• Progestin Antagonist [EPC]

NDC Crossover Matching brand name "Mifepristone" or generic name "Mifepristone"

NDC	Brand Name	Generic Name
43393-001	Mifepristone	MIFEPRISTONE
83114-001	MIFEPRISTONE	mifepristone
76346-073	Korlym	Mifepristone