NDC codes

FDA NDC Directory
Product NDC (as listed)65250-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65250-0003Add 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 NDC11-digit (billing)PackageCopy
65250-003-01652500003011 KIT in 1 CARTON (65250-003-01) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (65250-001-01) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (65250-002-01)Marketed from Oct 6, 2017

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)
Zilretta
Generic name (nonproprietary)
triamcinolone acetonide extended-release injectable suspension
Dosage form
Kit
Route
Intra-articular
Labeler
Pacira Pharmaceuticals, Inc.NDC labeler code 65250
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 208845
Marketing start
Listing expires
Identifiers
Product ID 65250-003_9806c4e8-2b5d-4e6b-915b-60426d912fb3SPL ID 9806c4e8-2b5d-4e6b-915b-60426d912fb3SPL set ID cd5c4673-21f2-4126-9556-da847b3a228bRxCUI 1947131, 1947133

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

N465250000301 followed by a unit qualifier and the quantity

Package 65250-0003-01. 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)

ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. ZILRETTA is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. ( 1 ) Limitation of Use The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. ( 2.1 ) Limitation of Use The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. [see Dosage and Administration (2.1) ] .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65250-003

What is NDC 65250-003?
65250-003 is the product NDC for Zilretta kit, listed with the FDA by Pacira Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zilretta (Triamcinolone acetonide extended-release injectable suspension).
Who is the labeler?
Pacira Pharmaceuticals, Inc., NDC labeler code 65250. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zilretta?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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