Prescription drug · ANDA
Mycophenolic Acid NDC 59651-621
Mycophenolate sodium 180 mg/1 · Tablet, Delayed release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-621-08 | 5965106210859651062108 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-621-08)Marketed from Feb 27, 2024 |
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)
- mycophenolic acid
- Active ingredients
- Mycophenolate sodium — 180 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218603
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-621_c88372f5-7138-434f-b730-5b3b6f86ec4dSPL ID c88372f5-7138-434f-b730-5b3b6f86ec4d
- 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
N459651062108followed by a unit qualifier and the quantityPackage 59651-0621-08. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 59651-621
- What is NDC 59651-621?
- 59651-621 is the product NDC for Mycophenolic Acid, Mycophenolate sodium 180 mg/1 tablet, delayed release, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mycophenolic Acid.
- What is the active ingredient?
- Mycophenolate sodium.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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?
- 34 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 180 mg/1 | Tablet, Delayed releaseOral | Novugen Pharma (USA) LLC. | 82293-012 | 82293-0012-10 |
| Mycophenolic Acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Novugen Pharma (USA) LLC. | 82293-013 | 82293-0013-10 |
Other NDCs under ANDA 218603
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 Acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Aurobindo Pharma Limited | 59651-622 |