NDC codes

FDA NDC Directory
Product NDC (as listed)0013-2651Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00013-2651Add 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
0013-2651-02000132651027 CARTRIDGE in 1 CARTON (0013-2651-02) / 1 KIT in 1 CARTRIDGEMarketed from Dec 20, 1995

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)
Genotropin
Generic name (nonproprietary)
somatropin
Dosage form
Kit
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 020280
Marketing start
Listing expires
Identifiers
Product ID 0013-2651_5aa3307a-c0bc-43c0-8177-3bb1cad66d7aSPL ID 5aa3307a-c0bc-43c0-8177-3bb1cad66d7aSPL set ID ffebf88b-d257-4542-9808-74d9b7167765RxCUI 241975, 762830, 762833, 762834, 762836, 762837, 762839, 762841, 762843, 762846, 762849, 762850, 762852, 762857, 762859, 762866, 762868, 762873, 762875, 762895, 762897, 763488, 763489, 996558, 996559

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

N400013265102 followed by a unit qualifier and the quantity

Package 00013-2651-02. 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)

GENOTROPIN is a recombinant human growth hormone indicated for: • Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature ( 1.1 ) • Adult: Treatment of adults with either adult onset or childhood onset GHD ( 1.2 ) 1.1 Pediatric Patients GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate g…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 020280

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

FDA NDC Directory listings under BLA 020280
ProductStrengthForm · routeLabelerProduct NDC
Genotropinsomatropin—KitPfizer Laboratories Div Pfizer Inc0013-2649
Genotropinsomatropin—KitPfizer Laboratories Div Pfizer Inc0013-2656
Genotropinsomatropin—KitPfizer Laboratories Div Pfizer Inc0013-2626
Genotropinsomatropin—KitPfizer Laboratories Div Pfizer Inc0013-2652
Genotropinsomatropin—KitPfizer Laboratories Div Pfizer Inc0013-2650
Genotropinsomatropin—KitPfizer Laboratories Div Pfizer Inc0013-2657
Genotropinsomatropin—KitPfizer Laboratories Div Pfizer Inc0013-2646
Genotropinsomatropin—KitPfizer Laboratories Div Pfizer Inc0013-2654
Genotropinsomatropin—KitPfizer Laboratories Div Pfizer Inc0013-2655
Genotropinsomatropin—KitPfizer Laboratories Div Pfizer Inc0013-2653
Genotropinsomatropin—KitPfizer Laboratories Div Pfizer Inc0013-2658

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