Prescription drug · BLA
Somavert (Pegvisomant) NDC 0009-7166
Kit · Pharmacia & Upjohn Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0009-7166-01 | 00009716601 | 1 KIT in 1 CARTON (0009-7166-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5175-02) * 1 mL in 1 SYRINGE (0009-5936-01)Marketed from Oct 1, 2016 | |
| 0009-7166-30 | 00009716630 | 30 KIT in 1 CARTON (0009-7166-30) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5175-02) * 1 mL in 1 SYRINGE (0009-5936-01)Marketed from Jan 17, 2022 |
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)
- Somavert
- Generic name (nonproprietary)
- pegvisomant
- Dosage form
- Kit
- Labeler
- Pharmacia & Upjohn Company LLCNDC labeler code 0009
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 021106
- Marketing start
- Listing expires
- Identifiers
- Product ID 0009-7166_36dc9264-0f75-4059-ac68-65fa4bfcdcc2SPL ID 36dc9264-0f75-4059-ac68-65fa4bfcdcc2SPL set ID 3cbb485b-6df1-49ce-8747-592b395b1988RxCUI 403806, 403807, 403808, 404457, 404458, 404459, 1549323, 1549452, 1549454, 1549456
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
N400009716601followed by a unit qualifier and the quantityPackage 00009-7166-01. 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)
SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels. SOMAVERT is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0009-7166
- What is NDC 0009-7166?
- 0009-7166 is the product NDC for Somavert (pegvisomant) kit, listed with the FDA by Pharmacia & Upjohn Company LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Somavert (Pegvisomant).
- Who is the labeler?
- Pharmacia & Upjohn Company LLC, NDC labeler code 0009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Somavert?
- 4 other product NDCs are listed under this name. See all Somavert NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Somavert products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Somavertpegvisomant | — | Kit | Pharmacia & Upjohn Company LLC | 0009-7168 | 00009-7168-0100009-7168-30 |
| Somavertpegvisomant | — | Kit | Pharmacia & Upjohn Company LLC | 0009-7188 | 00009-7188-0100009-7188-30 |
| Somavertpegvisomant | — | Kit | Pharmacia & Upjohn Company LLC | 0009-7199 | 00009-7199-0100009-7199-30 |
| Somavertpegvisomant | — | Kit | Pharmacia & Upjohn Company LLC | 0009-7200 | 00009-7200-0100009-7200-30 |
Other NDCs under BLA 021106
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Somavertpegvisomant | — | Kit | Pharmacia & Upjohn Company LLC | 0009-7168 |
| Somavertpegvisomant | — | Kit | Pharmacia & Upjohn Company LLC | 0009-7188 |
| Somavertpegvisomant | — | Kit | Pharmacia & Upjohn Company LLC | 0009-7199 |
| Somavertpegvisomant | — | Kit | Pharmacia & Upjohn Company LLC | 0009-7200 |