What is NDC 16729-223?

16729-223 is the product NDC for Temsirolimus kit, listed with the FDA by Accord Healthcare Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Accord Healthcare Inc., NDC labeler code 16729. 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 16729-223 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-223Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0223Add 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
16729-223-61	1672902236116729022361	1 KIT in 1 KIT (16729-223-61) * 1 mL in 1 VIAL, SINGLE-DOSE (16729-221-30) * 1.8 mL in 1 VIAL, SINGLE-DOSE (16729-222-30)Marketed from Aug 13, 2018

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
Labeler: Accord Healthcare Inc.NDC labeler code 16729
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203153
Marketing start: Aug 13, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 16729-223_116814b6-e438-8a45-e063-6394a90a9fadSPL ID 116814b6-e438-8a45-e063-6394a90a9fadSPL set ID ae8d2354-7ddb-41b8-9d55-77c84782b18fRxCUI 722289UPC 0316729222303

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

N416729022361 followed by a unit qualifier and the quantity

Package 16729-0223-61. 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 Feb 15, 2024.

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 16729-223

What is NDC 16729-223?: 16729-223 is the product NDC for Temsirolimus kit, listed with the FDA by Accord Healthcare Inc.. 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?: Accord Healthcare Inc., NDC labeler code 16729. 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)
Temsirolimus	—	KitIntravenous	Fresenius Kabi USA, LLC	65219-200	65219-0200-05
Temsirolimustemsirolimus injection	—	Kit	Almaject, Inc.	72611-785	72611-0785-02
Temsirolimustemsirolimus injection	—	Kit	Gland Pharma Limited	68083-202	68083-0202-01