What is NDC 65219-200?

65219-200 is the product NDC for Temsirolimus kit, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 65219. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Temsirolimus NDC 65219-200 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0200Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65219-200-05	65219020005	1 KIT in 1 KIT (65219-200-05) * 1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05) * 1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05)Marketed from Nov 20, 2020

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
Dosage form: Kit
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207383
Marketing start: Nov 20, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 65219-200_2b33d5f1-198e-41ef-ac78-ccfd27fc137aSPL ID 2b33d5f1-198e-41ef-ac78-ccfd27fc137aSPL set ID 1c207bed-10e3-46f0-ad2c-69d5e5c97736RxCUI 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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N465219020005 followed by a unit qualifier and the quantity

Package 65219-0200-05. 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 Mar 30, 2020.

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.

Full label on DailyMed (opens in a new tab)

About NDC 65219-200

What is NDC 65219-200?: 65219-200 is the product NDC for Temsirolimus kit, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Temsirolimus.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 65219. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Temsirolimus NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Temsirolimustemsirolimus injection	—	Kit	Almaject, Inc.	72611-785	72611-0785-02
Temsirolimustemsirolimus injection	—	Kit	Gland Pharma Limited	68083-202	68083-0202-01
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.

FDA NDC Directory listings under ANDA 207383
Product	Strength	Form · route	Labeler	Product NDC
Temsirolimustemsirolimus injection	—	Kit	Gland Pharma Limited	68083-202
Temsirolimustemsirolimus injection	—	Kit	Almaject, Inc.	72611-785