Prescription drug · ANDA
Mycophenolic Acid NDC 70377-039
Mycophenolate sodium 180 mg/1 · Tablet, Delayed release · Oral · Biocon Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70377-039-11 | 7037700391170377003911 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-039-11)Marketed from May 30, 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)
- mycophenolic acid
- Active ingredients
- Mycophenolate sodium — 180 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Biocon Pharma Inc.NDC labeler code 70377
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214630
- Marketing start
- Listing expires
- Identifiers
- Product ID 70377-039_dd78e397-2a86-a739-d8f3-f01f37985a14SPL ID dd78e397-2a86-a739-d8f3-f01f37985a14SPL set ID 8516e135-5cc0-ef2d-6dad-0f9f841bb27bRxCUI 485020, 485023UNII WX877SQI1GUPC 0370377040115
- 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
N470377003911followed by a unit qualifier and the quantityPackage 70377-0039-11. 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 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 tran…
Excerpt only. Read the full label for complete information.
About NDC 70377-039
- What is NDC 70377-039?
- 70377-039 is the product NDC for Mycophenolic Acid, Mycophenolate sodium 180 mg/1 tablet, delayed release, listed with the FDA by Biocon Pharma Inc.. 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?
- Biocon Pharma Inc., NDC labeler code 70377. 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 214630
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 | Biocon Pharma Inc. | 70377-040 |