What is NDC 65757-653?

65757-653 is the product NDC for olanzapine and samidorphan l-malate, Olanzapine 15 mg/1; Samidorphan l-malate 10 mg/1 tablet, film coated, listed with the FDA by Alkermes, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Olanzapine, Samidorphan l-malate.

Alkermes, Inc., NDC labeler code 65757. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for olanzapine and samidorphan l-malate?

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.

olanzapine and samidorphan l-malate NDC 65757-653

Unfinished product

This listing is a drug for further processing, not a finished drug product dispensed or administered to patients. It is not normally billed.

NDC codes

FDA NDC Directory

Product NDC (as listed)65757-653Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65757-0653Add 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
65757-653-03	65757065303	153846 TABLET, FILM COATED in 1 CONTAINER (65757-653-03)Marketed from 28-MAY-21

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

Generic name (nonproprietary): olanzapine and samidorphan l-malate
Active ingredients: Olanzapine — 15 mg/1Samidorphan l-malate — 10 mg/1
Dosage form: Tablet, Film coated
Labeler: Alkermes, Inc.NDC labeler code 65757
Product type: Drug for further processing
Marketing category: Drug for further processing
Marketing start: May 28, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 65757-653_9fbeda7f-959c-4e67-a516-03689a41ffaeSPL ID 9fbeda7f-959c-4e67-a516-03689a41ffae

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

N465757065303 followed by a unit qualifier and the quantity

Package 65757-0653-03. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 65757-653

What is NDC 65757-653?: 65757-653 is the product NDC for olanzapine and samidorphan l-malate, Olanzapine 15 mg/1; Samidorphan l-malate 10 mg/1 tablet, film coated, listed with the FDA by Alkermes, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: olanzapine and samidorphan l-malate.
What is the active ingredient?: Olanzapine, Samidorphan l-malate.
Who is the labeler?: Alkermes, Inc., NDC labeler code 65757. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for olanzapine and samidorphan l-malate?: 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.