Prescription drug · BLA
Pre-Pen (Benzylpenicilloyl polylysine) NDC 49471-001
Benzylpenicilloyl polylysine 60 umol/.25mL · Injection · Intradermal, Subcutaneous · ALK-ABELLO, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49471-001-05 | 49471000105 | 5 AMPULE in 1 CARTON (49471-001-05) / .25 mL in 1 AMPULEMarketed from Jul 25, 1974 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Pre-Pen
- Generic name (nonproprietary)
- benzylpenicilloyl polylysine
- Active ingredients
- Benzylpenicilloyl polylysine — 60 umol/.25mL
- Dosage form
- Injection
- Route
- Intradermal, Subcutaneous
- Labeler
- ALK-ABELLO, INC.NDC labeler code 49471
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 050114
- Marketing start
- Listing expires
- Identifiers
- Product ID 49471-001_630c84ab-994f-4686-99bc-deaf6db7cff2SPL ID 630c84ab-994f-4686-99bc-deaf6db7cff2SPL set ID 2fbcc40c-f102-4abe-bce5-a93de95874feUNII 76479814OY
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.
- NDC on a medical claim
N449471000105followed by a unit qualifier and the quantityPackage 49471-0001-05. 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)
INDICATIONS AND USAGE: PRE-PEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. A negative skin test to PRE-PEN is associated with an incidence of immediate allergic reactions of less than 5% after the administration of therapeutic penicillin, whereas the incidence may be more than 50% in a history-positive patient with a positive skin test to PRE-PEN. These allergic reactions are predominantly dermatologic. Whether a negative skin test to PRE-PEN predicts a lower risk of anaphylaxis is not established. Similarly, when deciding the risk of proposed penicillin treatment, there …
Excerpt only. Read the full label for complete information.
About NDC 49471-001
- What is NDC 49471-001?
- 49471-001 is the product NDC for Pre-Pen (benzylpenicilloyl polylysine), Benzylpenicilloyl polylysine 60 umol/.25mL injection, listed with the FDA by ALK-ABELLO, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pre-Pen (Benzylpenicilloyl polylysine).
- What is the active ingredient?
- Benzylpenicilloyl polylysine.
- Who is the labeler?
- ALK-ABELLO, INC., NDC labeler code 49471. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pre-Pen?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.