What is NDC 61168-101?

61168-101 is the product NDC for Kybella (deoxycholic acid), Deoxycholic acid 20 mg/2mL injection, solution, listed with the FDA by Kythera Biopharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Kythera Biopharmaceuticals Inc., NDC labeler code 61168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Kybella?

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.

Kybella NDC 61168-101 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61168-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61168-0101Add 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
61168-101-03	61168010103	2 VIAL, GLASS in 1 CARTON (61168-101-03) / 2 mL in 1 VIAL, GLASSMarketed from Aug 1, 2018 · Sample package
61168-101-04	61168010104	4 VIAL, GLASS in 1 CARTON (61168-101-04) / 2 mL in 1 VIAL, GLASS (61168-101-01)Marketed from Jun 8, 2015

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): Kybella
Generic name (nonproprietary): deoxycholic acid
Active ingredients: Deoxycholic acid — 20 mg/2mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Kythera Biopharmaceuticals Inc.NDC labeler code 61168
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 206333
Marketing start: Jun 8, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Cell Membrane Integrity (Physiologic effect)
Identifiers: Product ID 61168-101_8125c34a-6f8e-47d8-bcd2-1b8cf1ce8a7aSPL ID 8125c34a-6f8e-47d8-bcd2-1b8cf1ce8a7a
Pharmacologic class: Cytolytic Agent

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

N461168010103 followed by a unit qualifier and the quantity

Package 61168-0101-03. 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 61168-101

What is NDC 61168-101?: 61168-101 is the product NDC for Kybella (deoxycholic acid), Deoxycholic acid 20 mg/2mL injection, solution, listed with the FDA by Kythera Biopharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Kybella (Deoxycholic Acid).
What is the active ingredient?: Deoxycholic acid.
Who is the labeler?: Kythera Biopharmaceuticals Inc., NDC labeler code 61168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Kybella?: 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.

Kybella (Deoxycholic acid) NDC 61168-101