NDC codes

FDA NDC Directory
Product NDC (as listed)72572-422Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72572-0422Add 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
72572-422-01725720422011 SYRINGE in 1 CARTON (72572-422-01) / 3 mL in 1 SYRINGEMarketed from Oct 30, 2025
72572-422-05725720422055 SYRINGE in 1 CARTON (72572-422-05) / 3 mL in 1 SYRINGEMarketed from Oct 30, 2025

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)
Insulin Glargine
Generic name (nonproprietary)
insulin glargine-yfgn
Active ingredients
Insulin glargine100 [iU]/mL
Dosage form
Injection, Solution
Route
Subcutaneous
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 761201
Marketing start
Listing expires
Other FDA classes
Insulin (Chemical structure)
Identifiers
Product ID 72572-422_83f8663d-cb21-9b78-e315-e0db15befb18SPL ID 83f8663d-cb21-9b78-e315-e0db15befb18SPL set ID 72cfe377-52f6-0348-fc71-5d4ac1992ffbRxCUI 2563971UNII 2ZM8CX04RZ
Pharmacologic class
Insulin Analog

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

N472572042201 followed by a unit qualifier and the quantity

Package 72572-0422-01. 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 .

Indications (excerpt from the label)

Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis. Insulin Glargine-yfgn is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761201

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

FDA NDC Directory listings under BLA 761201
ProductStrengthForm · routeLabelerProduct NDC
Insulin Glargineinsulin glargine-yfgnInsulin glargine 100 [iU]/mLInjection, SolutionSubcutaneousBiocon Biologics Inc.83257-015
Semgleeinsulin glargine-yfgnInsulin glargine 100 [iU]/mLInjection, SolutionSubcutaneousBiocon Biologics Inc.83257-011
Semgleeinsulin glargine-yfgnInsulin glargine 100 [iU]/mLInjection, SolutionSubcutaneousBiocon Biologics Inc.83257-012
Insulin Glargineinsulin glargine-yfgnInsulin glargine 100 [iU]/mLInjection, SolutionSubcutaneousBiocon Biologics Inc.83257-014
Insulin Glargineinsulin glargine-yfgnInsulin glargine 100 [iU]/mLInjection, SolutionSubcutaneousCivica, Inc.72572-424

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