NDC 53002-1630

Ella

Ulipristal Acetate

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

• Product ID: 53002-1630_0a889280-cfaa-4bba-aa2a-35c0d1dfc00d
• NDC: 53002-1630
• 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: RPK Pharmaceuticals, Inc.
• 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: 2021-12-31

Packaging

NDC 53002-1630-1

1 TABLET in 1 DOSE PACK (53002-1630-1)

• Marketing Start Date: 2018-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53002-1630-1 [53002163001]

Ella TABLET

• Marketing Category: NDA
• Application Number: NDA022474
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-02
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ULIPRISTAL ACETATE	30 mg/1

OpenFDA Data

• SPL SET ID: 04bb31a9-1682-4941-a7cb-a6526d226776
• Manufacturer:
  • RPK Pharmaceuticals, Inc.
• 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