NDC codes

FDA NDC Directory
Product NDC (as listed)0338-0126Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00338-0126Add 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
0338-0126-120033801261212 CONTAINER in 1 CARTON (0338-0126-12) / 100 mL in 1 CONTAINERMarketed from Jul 12, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Myxredlin
Generic name (nonproprietary)
insulin human
Active ingredients
Insulin human1 [iU]/mL
Dosage form
Injection, Solution
Route
Intravenous
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 208157
Marketing start
Listing expires
Other FDA classes
Insulin (Chemical structure)
Identifiers
Product ID 0338-0126_9642c441-5143-410a-af83-db5daded5420SPL ID 9642c441-5143-410a-af83-db5daded5420SPL set ID afca6e80-a802-49fb-a978-5fe28a173001RxCUI 2179744, 2179749UNII 1Y17CTI5SR
Pharmacologic class
Insulin

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

N400338012612 followed by a unit qualifier and the quantity

Package 00338-0126-12. 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)

MYXREDLIN is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. MYXREDLIN is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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