NDC 0074-0039

Orilissa

Elagolix

Orilissa is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Elagolix Sodium.

• Product ID: 0074-0039_10c7c8a9-573a-02a3-97b4-50f953145beb
• NDC: 0074-0039
• Product Type: Human Prescription Drug
• Proprietary Name: Orilissa
• Generic Name: Elagolix
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-23
• Marketing Category: NDA / NDA
• Application Number: NDA210450
• Labeler Name: AbbVie Inc.
• Substance Name: ELAGOLIX SODIUM
• Active Ingredient Strength: 200 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0074-0039-14

1 BLISTER PACK in 1 CARTON (0074-0039-14) > 14 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2018-07-23
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 0074-0039-01 [00074003901]

Orilissa TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210450
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-23

NDC 0074-0039-56 [00074003956]

Orilissa TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210450
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-23

NDC 0074-0039-14 [00074003914]

Orilissa TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210450
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-23

Drug Details

Active Ingredients

Ingredient	Strength
ELAGOLIX SODIUM	200 mg/1

OpenFDA Data

• SPL SET ID: a86757b3-09c5-fd3b-1223-244e94f50a66
• Manufacturer:
  • AbbVie Inc.
• UNII:
  • 5948VUI423
• RxNorm Concept Unique ID - RxCUI:
  • 2049860
  • 2049862
  • 2049858
  • 2049852
• UPC Code:
  • 0300740038012
  • 0300740038074

NDC Crossover Matching brand name "Orilissa" or generic name "Elagolix"

NDC	Brand Name	Generic Name
0074-0038	Orilissa	Elagolix
0074-0039	Orilissa	Elagolix