NDC 69539-033

Teriflunomide

Teriflunomide

Teriflunomide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Msn Laboratories Private Limited. The primary component is Teriflunomide.

• Product ID: 69539-033_3d2eaa09-9ce4-4494-b9a5-71689809b20b
• NDC: 69539-033
• Product Type: Human Prescription Drug
• Proprietary Name: Teriflunomide
• Generic Name: Teriflunomide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209623
• Labeler Name: MSN LABORATORIES PRIVATE LIMITED
• Substance Name: TERIFLUNOMIDE
• Active Ingredient Strength: 14 mg/1
• Pharm Classes: Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 69539-033-41

2 BLISTER PACK in 1 CARTON (69539-033-41) > 14 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2019-04-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69539-033-41 [69539003341]

Teriflunomide TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209623
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-24

Drug Details

Active Ingredients

Ingredient	Strength
TERIFLUNOMIDE	14 mg/1

Pharmacological Class

• Pyrimidine Synthesis Inhibitor [EPC]
• Dihydroorotate Dehydrogenase Inhibitors [MoA]
• Pyrimidine Synthesis Inhibitor [EPC]
• Dihydroorotate Dehydrogenase Inhibitors [MoA]

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

NDC	Brand Name	Generic Name
0115-1565	Teriflunomide	Teriflunomide
68462-311	teriflunomide	teriflunomide
68462-312	teriflunomide	teriflunomide
69238-1303	Teriflunomide	Teriflunomide
69238-1304	Teriflunomide	Teriflunomide
69539-032	Teriflunomide	Teriflunomide
69539-033	Teriflunomide	Teriflunomide
58468-0210	Aubagio	teriflunomide
58468-0211	Aubagio	teriflunomide