Prescription drug · ANDA
Temsirolimus (Temsirolimus injection) NDC 68083-202
Kit · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-202-01 | 6808302020168083020201 | 1 KIT in 1 CARTON (68083-202-01) * 1 mL in 1 VIAL, SINGLE-USE (68083-200-01) * 1.8 mL in 1 VIAL, SINGLE-USE (68083-201-01)Marketed from Aug 26, 2019 |
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)
- Temsirolimus
- Generic name (nonproprietary)
- temsirolimus injection
- Dosage form
- Kit
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207383
- Marketing start
- Listing expires
- Identifiers
- Product ID 68083-202_6dd61a73-2d62-4f94-9617-643d8b896fdeSPL ID 6dd61a73-2d62-4f94-9617-643d8b896fdeSPL set ID d7ee3165-175d-4439-8740-fbfed18aaf0eRxCUI 722289
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N468083020201followed by a unit qualifier and the quantityPackage 68083-0202-01. 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 .
Indications (excerpt from the label)
Temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma. Temsirolimus injection is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. (1)
Excerpt only. Read the full label for complete information.
About NDC 68083-202
- What is NDC 68083-202?
- 68083-202 is the product NDC for Temsirolimus (temsirolimus injection) kit, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Temsirolimus (Temsirolimus Injection).
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Temsirolimus?
- 3 other product NDCs are listed under this name. See all Temsirolimus NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Temsirolimus products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Temsirolimus | — | KitIntravenous | Fresenius Kabi USA, LLC | 65219-200 | 65219-0200-05 |
| Temsirolimustemsirolimus injection | — | Kit | Almaject, Inc. | 72611-785 | 72611-0785-02 |
| Temsirolimus | — | Kit | Accord Healthcare Inc. | 16729-223 | 16729-0223-61 |
Other NDCs under ANDA 207383
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 |
|---|---|---|---|---|
| Temsirolimus | — | KitIntravenous | Fresenius Kabi USA, LLC | 65219-200 |
| Temsirolimustemsirolimus injection | — | Kit | Almaject, Inc. | 72611-785 |