NDC codes

FDA NDC Directory
Product NDC (as listed)50090-0353Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-0353Add 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
50090-0353-0500900353001 VIAL in 1 CARTON (50090-0353-0) / 10 mL in 1 VIALMarketed from Apr 30, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Humulin R
Generic name (nonproprietary)
insulin human
Active ingredients
Insulin human100 [iU]/mL
Dosage form
Injection, Solution
Route
Parenteral
Product type
Over-the-counter drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 018780
Marketing start
Listing expires
Other FDA classes
Insulin (Chemical structure)
Identifiers
Product ID 50090-0353_87a75165-353b-4c21-b82d-4ccbd893f881SPL ID 87a75165-353b-4c21-b82d-4ccbd893f881SPL set ID 81199e55-ade9-46de-a5a3-c0415acee403RxCUI 311034, 311036UNII 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.

NDC on a medical claim

N450090035300 followed by a unit qualifier and the quantity

Package 50090-0353-00. 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)

HUMULIN R is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMULIN ® R is a short-acting human insulin indicated to improve glycemic control in adult 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)

Other NDCs under BLA 018780

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

FDA NDC Directory listings under BLA 018780
ProductStrengthForm · routeLabelerProduct NDC
Humulin R U-500 KwikPeninsulin humanInsulin human 500 [iU]/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-8824
Humulin Rinsulin humanInsulin human 100 [iU]/mLInjection, SolutionParenteralEli Lilly and Company0002-0213
Humulin Rinsulin humanInsulin human 100 [iU]/mLInjection, SolutionParenteralEli Lilly and Company0002-8215

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