NDC codes

FDA NDC Directory
Product NDC (as listed)0002-8147Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00002-8147Add 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
0002-8147-01000028147011 TRAY in 1 CARTON (0002-8147-01) / 1 KIT in 1 TRAY * 2.88 mL in 1 CARTRIDGE (0002-7554-01) * 2.88 mL in 1 SYRINGE (0002-7618-01)Marketed from Jan 27, 2006

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)
Humatrope
Generic name (nonproprietary)
somatropin
Dosage form
Kit
Route
Intramuscular, Subcutaneous
Labeler
Eli Lilly and CompanyNDC labeler code 0002
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 019640
Marketing start
Marketing end
Identifiers
Product ID 0002-8147_32f865e2-68df-47bc-b392-21b696a9f845SPL ID 32f865e2-68df-47bc-b392-21b696a9f845SPL set ID a774e1ae-3997-49ee-8b0e-99a2b315d409RxCUI 582969, 582971, 582974, 582976, 729232, 729234

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

N400002814701 followed by a unit qualifier and the quantity

Package 00002-8147-01. 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)

HUMATROPE is a recombinant human growth hormone indicated for: Pediatric Patients: growth failure due to inadequate secretion of endogenous growth hormone (GH); short stature associated with Turner syndrome; Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range; short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency; short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. ( 1.1 ) Adult Patients: replacement of endogenous GH in adults with GH deficiency. ( 1.2 ) 1.1 Pediatric Patients HU…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0002-8147

What is NDC 0002-8147?
0002-8147 is the product NDC for Humatrope (somatropin) kit, listed with the FDA by Eli Lilly and Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Humatrope (Somatropin).
Who is the labeler?
Eli Lilly and Company, NDC labeler code 0002. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Humatrope?
2 other product NDCs are listed under this name. See all Humatrope 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 Humatrope NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Humatropesomatropin—KitIntramuscular, SubcutaneousEli Lilly and Company0002-814900002-8149-01
Humatropesomatropin—KitIntramuscular, SubcutaneousEli Lilly and Company0002-814800002-8148-01

Other NDCs under BLA 019640

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

FDA NDC Directory listings under BLA 019640
ProductStrengthForm · routeLabelerProduct NDC
Humatropesomatropin—KitIntramuscular, SubcutaneousEli Lilly and Company0002-8149
Humatropesomatropin—KitIntramuscular, SubcutaneousEli Lilly and Company0002-8148

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