Prescription drug · ANDA
Mycophenolic Acid (Mycophenilic acid) NDC 72819-155
Mycophenolic acid 180 mg/1 · Tablet, Delayed release · Oral · Archis Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72819-155-08 | 72819015508 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (72819-155-08)Marketed from Feb 21, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mycophenolic Acid
- Generic name (nonproprietary)
- mycophenilic acid
- Active ingredients
- Mycophenolic acid — 180 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Archis Pharma LLCNDC labeler code 72819
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091248
- Marketing start
- Listing expires
- Identifiers
- Product ID 72819-155_471a0acf-310d-7b67-e063-6294a90adb0eSPL ID 471a0acf-310d-7b67-e063-6294a90adb0eSPL set ID 30cb1078-929b-4c0f-be1d-49ef352dfab9RxCUI 485020, 485023UNII HU9DX48N0TUPC 0378819155021
- Pharmacologic class
- Antimetabolite Immunosuppressant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472819015508followed by a unit qualifier and the quantityPackage 72819-0155-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1 ) Use in combination with cyclosporine and corticosteroids. ( 1.1 ) Limitations of Use: Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney t…
Excerpt only. Read the full label for complete information.
About NDC 72819-155
- What is NDC 72819-155?
- 72819-155 is the product NDC for Mycophenolic Acid (mycophenilic acid), Mycophenolic acid 180 mg/1 tablet, delayed release, listed with the FDA by Archis Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mycophenolic Acid (Mycophenilic acid).
- What is the active ingredient?
- Mycophenolic acid.
- Who is the labeler?
- Archis Pharma LLC, NDC labeler code 72819. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mycophenolic Acid?
- 38 other product NDCs are listed under this name. See all Mycophenolic Acid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mycophenolic Acid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| mycophenolic acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | Stellon Biotech Inc. | 85972-161 | 85972-0161-12 |
| mycophenolic acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Stellon Biotech Inc. | 85972-162 | 85972-0162-12 |
| Mycophenolic Acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | Ascend Laboratories, LLC | 67877-928 | 67877-0928-0567877-0928-1267877-0928-38 |
| Mycophenolic Acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Ascend Laboratories, LLC | 67877-929 | 67877-0929-0567877-0929-1267877-0929-38 |
| Mycophenolic Acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-4391 | 70518-4391-00 |
| Mycophenolic Acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Major Pharmaceuticals | 0904-7372 | 00904-7372-0400904-7372-61 |
| Mycophenolic Acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | Biocon Pharma Inc. | 70377-126 | 70377-0126-11 |
| Mycophenolic Acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Biocon Pharma Inc. | 70377-127 | 70377-0127-11 |
| Mycophenolic Acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Novugen Pharma (USA) LLC. | 82293-013 | 82293-0013-10 |
| Mycophenolic Acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | Novugen Pharma (USA) LLC. | 82293-012 | 82293-0012-10 |
Other NDCs under ANDA 091248
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Mycophenolic Acidmycophenilic acid | Mycophenolic acid 360 mg/1 | Tablet, Delayed releaseOral | Archis Pharma LLC | 72819-156 |