NDC 70748-218

mycophenolic acid

Mycophenolic Acid

mycophenolic acid is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Mycophenolate Sodium.

• Product ID: 70748-218_3446a90d-9272-43e1-839c-5cf802112211
• NDC: 70748-218
• Product Type: Human Prescription Drug
• Proprietary Name: mycophenolic acid
• Generic Name: Mycophenolic Acid
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2020-03-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA211173
• Labeler Name: Lupin Pharmaceuticals, Inc.
• Substance Name: MYCOPHENOLATE SODIUM
• Active Ingredient Strength: 360 mg/1
• Pharm Classes: Antimetabolite Immunosuppressant [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70748-218-16

120 TABLET, DELAYED RELEASE in 1 BOTTLE (70748-218-16)

• Marketing Start Date: 2020-04-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70748-218-16 [70748021816]

mycophenolic acid TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA211173
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-04-03

Drug Details

Active Ingredients

Ingredient	Strength
MYCOPHENOLATE SODIUM	360 mg/1

OpenFDA Data

• SPL SET ID: 3edad5ae-10ab-48c8-829c-781ec5a0bbf8
• Manufacturer:
  • Lupin Pharmaceuticals, Inc.
• UNII:
  • WX877SQI1G
• RxNorm Concept Unique ID - RxCUI:
  • 485023
  • 485020
• UPC Code:
  • 0370748217160
  • 0370748218167

Pharmacological Class

• Antimetabolite Immunosuppressant [EPC]

NDC Crossover Matching brand name "mycophenolic acid" or generic name "Mycophenolic Acid"

NDC	Brand Name	Generic Name
0093-7031	Mycophenolic Acid	Mycophenolic Acid
0093-7032	Mycophenolic Acid	Mycophenolic Acid
0378-4201	Mycophenolic Acid	Mycophenolic Acid
0378-4202	Mycophenolic Acid	Mycophenolic Acid
0904-6785	Mycophenolic Acid	Mycophenolic Acid
0904-6786	Mycophenolic Acid	Mycophenolic Acid
16729-189	Mycophenolic Acid	Mycophenolic Acid
16729-261	Mycophenolic Acid	Mycophenolic Acid
24979-160	mycophenolic acid	mycophenolic acid
24979-161	mycophenolic acid	mycophenolic acid
50268-559	Mycophenolic Acid	Mycophenolic Acid
68084-918	Mycophenolic Acid	Mycophenolic Acid
68084-907	Mycophenolic Acid	Mycophenolic Acid
51079-508	Mycophenolic Acid	Mycophenolic Acid
51079-509	Mycophenolic Acid	Mycophenolic Acid
60429-016	Mycophenolic Acid	Mycophenolic Acid
60505-2966	Mycophenolic Acid	Mycophenolic Acid
60505-2965	Mycophenolic Acid	Mycophenolic Acid
60429-017	Mycophenolic Acid	Mycophenolic Acid
68254-5001	mycophenolic acid	mycophenolic acid
68254-5002	mycophenolic acid	mycophenolic acid
70748-217	mycophenolic acid	mycophenolic acid
70748-218	mycophenolic acid	mycophenolic acid
50268-560	Mycophenolic Acid	Mycophenolic Acid
0078-0385	Myfortic	mycophenolic acid
0078-0386	Myfortic	mycophenolic acid