What is NDC 68083-600?

68083-600 is the product NDC for cetrorelix acetate kit, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

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 cetrorelix acetate?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

cetrorelix acetate NDC 68083-600 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-600Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0600Add 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
68083-600-01	6808306000168083060001	1 TRAY in 1 CARTON (68083-600-01) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (68083-598-01) * 1 mL in 1 SYRINGE (68083-599-01)Marketed from Apr 25, 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: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218150
Marketing start: Apr 25, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 68083-600_ab90e510-eecd-4d5f-b2df-059d3cbfc8f0SPL ID ab90e510-eecd-4d5f-b2df-059d3cbfc8f0SPL set ID 89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290aRxCUI 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

N468083060001 followed by a unit qualifier and the quantity

Package 68083-0600-01. 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 Aug 8, 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)

About NDC 68083-600

What is NDC 68083-600?: 68083-600 is the product NDC for cetrorelix acetate 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?: cetrorelix acetate.
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 cetrorelix acetate?: 4 other product NDCs are listed under this name. See all cetrorelix acetate 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 cetrorelix acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
cetrorelix acetate	—	Kit	FRESENIUS KABI USA, LLC	65219-292	65219-0292-77
Cetrorelix acetatecetrorelix acetate for injection	—	KitSubcutaneous	Apotex Corp.	60505-6270	60505-6270-01
Cetrorelix Acetate	—	KitSubcutaneous	Meitheal Pharmaceuticals Inc.	71288-558	71288-0558-90
Cetrorelix acetatecetrorelix acetate for injection	—	KitSubcutaneous	Qilu Pharmaceutical Co., Ltd.	67184-0605	67184-0605-02

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	FRESENIUS KABI USA, LLC	65219-292