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
44087-0004-7440870004071 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
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 020604
Marketing start
Listing expires
Identifiers
Product ID 44087-0004_4ca63d8e-15cf-4690-b148-2ad415bd0640SPL ID 4ca63d8e-15cf-4690-b148-2ad415bd0640SPL set ID 62b01d29-90f0-45b2-a0c4-3a750ba36c8aRxCUI 248288, 249453, 346494, 751566, 751568, 751570

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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

SEROSTIM (somatropin) is indicated for the treatment of adults with HIV and wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary. SEROSTIM is a human growth hormone (somatropin) indicated for the treatment of adults with HIV and wasting or cachexia to increase lean body mass and body weight, and improve physical endurance ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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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