NDC codes

FDA NDC Directory
Product NDC (as listed)44087-0004Labeler and product segments. Claims need a package NDC.
Product NDC at billing width44087-0004Add 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
44087-0004-744087000407440870004071 KIT in 1 CARTON (44087-0004-7) * 1 mL in 1 VIAL * 3.5 mL in 1 VIAL, GLASSMarketed from Jul 25, 1997

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)
Serostim
Generic name (nonproprietary)
somatropin
Dosage form
Kit
Route
Subcutaneous
Labeler
EMD Serono, Inc.NDC labeler code 44087
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 020604
Marketing start
Listing expires
Identifiers
Product ID 44087-0004_83f6e6c0-4286-450b-bc91-1b9aa53ad936SPL ID 83f6e6c0-4286-450b-bc91-1b9aa53ad936

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

N444087000407 followed by a unit qualifier and the quantity

Package 44087-0004-07. 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 44087-0004

What is NDC 44087-0004?
44087-0004 is the product NDC for Serostim (somatropin) kit, listed with the FDA by EMD Serono, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Serostim (Somatropin).
Who is the labeler?
EMD Serono, Inc., NDC labeler code 44087. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Serostim?
2 other product NDCs are listed under this name. See all Serostim NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Serostim NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Serostimsomatropin—KitSubcutaneousEMD Serono, Inc.44087-000544087-0005-07
Serostimsomatropin—KitSubcutaneousEMD Serono, Inc.44087-000644087-0006-07

Other NDCs under BLA 020604

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

FDA NDC Directory listings under BLA 020604
ProductStrengthForm · routeLabelerProduct NDC
Serostimsomatropin—KitSubcutaneousEMD Serono, Inc.44087-0005
Serostimsomatropin—KitSubcutaneousEMD Serono, Inc.44087-0006

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