NDC 50090-2835

Ella

Ulipristal Acetate

Ella is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Ulipristal Acetate.

• Product ID: 50090-2835_b083c9ba-7546-49f6-b3c2-c5cbec754fe7
• NDC: 50090-2835
• Product Type: Human Prescription Drug
• Proprietary Name: Ella
• Generic Name: Ulipristal Acetate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2010-08-13
• Marketing Category: NDA / NDA
• Application Number: NDA022474
• Labeler Name: A-S Medication Solutions
• Substance Name: ULIPRISTAL ACETATE
• Active Ingredient Strength: 30 mg/1
• Pharm Classes: Progesterone Agonist/Antagonist [EPC],Selective Progesterone Receptor Modulators [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50090-2835-0

1 BLISTER PACK in 1 CARTON (50090-2835-0) > 1 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2017-02-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-2835-0 [50090283500]

Ella TABLET

• Marketing Category: NDA
• Application Number: NDA022474
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-02
• Marketing End Date: 2019-05-31

Drug Details

Active Ingredients

Ingredient	Strength
ULIPRISTAL ACETATE	30 mg/1

OpenFDA Data

• SPL SET ID: 4bc8f664-d3af-4ca5-8bbd-7d120da8027d
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • YF7V70N02B
• RxNorm Concept Unique ID - RxCUI:
  • 1005924
  • 1005928

Pharmacological Class

• Progesterone Agonist/Antagonist [EPC]
• Selective Progesterone Receptor Modulators [MoA]

NDC Crossover Matching brand name "Ella" or generic name "Ulipristal Acetate"

NDC	Brand Name	Generic Name
50090-2835	Ella	ulipristal acetate
50090-5422	Ella	ulipristal acetate
50102-911	Ella	ulipristal acetate
53002-1630	Ella	ulipristal acetate
53002-2630	Ella	ulipristal acetate
73302-456	Ella	ulipristal acetate
82454-0456	Ella	ulipristal acetate