cetrorelix acetate NDC 65219-292

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-292Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0292Add 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
65219-292-77	65219029277	1 TRAY in 1 CARTON (65219-292-77) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (65219-290-02) * 1 mL in 1 SYRINGE (65219-286-01)Marketed from Jul 31, 2024

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): cetrorelix acetate
Generic name (nonproprietary): cetrorelix acetate
Dosage form: Kit
Labeler: FRESENIUS KABI USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218150
Marketing start: Jul 31, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 65219-292_96fa0188-c4cd-4e23-b376-457bd6df8e2fSPL ID 96fa0188-c4cd-4e23-b376-457bd6df8e2fSPL set ID c9c50fcb-b28d-4085-9116-b38a21d31b99RxCUI 283402

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

N465219029277 followed by a unit qualifier and the quantity

Package 65219-0292-77. 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 Jul 12, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218150

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218150
Product	Strength	Form · route	Labeler	Product NDC
cetrorelix acetate	—	Kit	Gland Pharma Limited	68083-600