NDC 46708-436

Leflunomide

Leflunomide

Leflunomide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Leflunomide.

• Product ID: 46708-436_e61a8fad-d513-4d27-aba0-e1a55b49c164
• NDC: 46708-436
• Product Type: Human Prescription Drug
• Proprietary Name: Leflunomide
• Generic Name: Leflunomide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-12-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091369
• Labeler Name: Alembic Pharmaceuticals Limited
• Substance Name: LEFLUNOMIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Antirheumatic Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 46708-436-30

30 TABLET in 1 BOTTLE (46708-436-30)

• Marketing Start Date: 2016-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46708-436-30 [46708043630]

Leflunomide TABLET

• Marketing Category: ANDA
• Application Number: ANDA091369
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-01

NDC 46708-436-60 [46708043660]

Leflunomide TABLET

• Marketing Category: ANDA
• Application Number: ANDA091369
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-01

NDC 46708-436-31 [46708043631]

Leflunomide TABLET

• Marketing Category: ANDA
• Application Number: ANDA091369
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-01

NDC 46708-436-71 [46708043671]

Leflunomide TABLET

• Marketing Category: ANDA
• Application Number: ANDA091369
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-01

Drug Details

Active Ingredients

Ingredient	Strength
LEFLUNOMIDE	10 mg/1

OpenFDA Data

• SPL SET ID: f6a4107e-b393-45ed-8e5a-70af5bd53826
• Manufacturer:
  • Alembic Pharmaceuticals Limited
• UNII:
  • G162GK9U4W
• RxNorm Concept Unique ID - RxCUI:
  • 205285
  • 205284
• UPC Code:
  • 0346708437305
  • 0346708436308

Pharmacological Class

• Antirheumatic Agent [EPC]

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

NDC	Brand Name	Generic Name
0955-1735	Leflunomide	leflunomide
0955-1737	Leflunomide	leflunomide
10702-277	Leflunomide	Leflunomide
10702-278	Leflunomide	Leflunomide
13811-677	Leflunomide	Leflunomide
13811-678	Leflunomide	Leflunomide
23155-043	Leflunomide	Leflunomide
68258-2992	Leflunomide	Leflunomide
23155-044	Leflunomide	Leflunomide
46708-437	Leflunomide	Leflunomide
46708-436	Leflunomide	Leflunomide
60505-2503	LEFLUNOMIDE	LEFLUNOMIDE
60505-2502	LEFLUNOMIDE	LEFLUNOMIDE
62332-062	Leflunomide	Leflunomide
62332-061	Leflunomide	Leflunomide
70710-1157	leflunomide	leflunomide
70710-1158	leflunomide	leflunomide
70771-1492	leflunomide	leflunomide
70771-1491	leflunomide	leflunomide
42291-420	LEFLUNOMIDE	LEFLUNOMIDE
42291-421	LEFLUNOMIDE	LEFLUNOMIDE
70748-130	Leflunomide	Leflunomide
70748-129	Leflunomide	Leflunomide
50268-477	LEFLUNOMIDE	LEFLUNOMIDE
50268-478	LEFLUNOMIDE	LEFLUNOMIDE
0088-2160	Arava	leflunomide
0088-2161	Arava	leflunomide
0088-2162	Arava	leflunomide