Prescription drug · BLA
Rebif (Interferon beta-1a) NDC 44087-0044
Interferon beta-1a 44 ug/.5mL · Injection, Solution · Subcutaneous · EMD Serono, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44087-0044-3 | 4408700440344087004403 | 12 SYRINGE, GLASS in 1 CARTON (44087-0044-3) / .5 mL in 1 SYRINGE, GLASS (44087-0044-9)Marketed from Mar 7, 2002 |
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)
- Rebif
- Generic name (nonproprietary)
- interferon beta-1a
- Active ingredients
- Interferon beta-1a — 44 ug/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- EMD Serono, Inc.NDC labeler code 44087
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103780
- Marketing start
- Listing expires
- Other FDA classes
- Interferon-beta (Chemical structure)
- Identifiers
- Product ID 44087-0044_037d2645-544b-41bb-bea8-00b578366ac6SPL ID 037d2645-544b-41bb-bea8-00b578366ac6SPL set ID c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0fRxCUI 758025, 758027, 758028, 758029, 758030, 758032, 795748, 795749, 1649994, 1649996, 1650003, 1650004, 1650011, 1650012, 1650268, 1650282UNII XRO4566Q4R
- Pharmacologic class
- Interferon beta
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
N444087004403followed by a unit qualifier and the quantityPackage 44087-0044-03. 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)
REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Rebif is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 44087-0044
- What is NDC 44087-0044?
- 44087-0044 is the product NDC for Rebif (interferon beta-1a), Interferon beta-1a 44 ug/.5mL injection, solution, listed with the FDA by EMD Serono, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rebif (Interferon beta-1a).
- What is the active ingredient?
- Interferon beta-1a.
- Who is the labeler?
- EMD Serono, Inc., NDC labeler code 44087. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rebif?
- 2 other product NDCs are listed under this name. See all Rebif NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rebif products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rebifinterferon beta-1a | — | KitSubcutaneous | EMD Serono, Inc. | 44087-8822 | 44087-8822-01 |
| Rebifinterferon beta-1a | Interferon beta-1a 22 ug/.5mL | Injection, SolutionSubcutaneous | EMD Serono, Inc. | 44087-0022 | 44087-0022-03 |
Other NDCs under BLA 103780
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 |
|---|---|---|---|---|
| Rebifinterferon beta-1a | Interferon beta-1a 22 ug/.5mL | Injection, SolutionSubcutaneous | EMD Serono, Inc. | 44087-0022 |
| Rebifinterferon beta-1a | — | KitSubcutaneous | EMD Serono, Inc. | 44087-8822 |
| Rebif Rebidoseinterferon beta-1a | — | KitSubcutaneous | EMD Serono, Inc. | 44087-0188 |
| Rebif Rebidoseinterferon beta-1a | Interferon beta-1a 22 ug/.5mL | Injection, SolutionSubcutaneous | EMD Serono, Inc. | 44087-3322 |
| Rebif Rebidoseinterferon beta-1a | Interferon beta-1a 44 ug/.5mL | Injection, SolutionSubcutaneous | EMD Serono, Inc. | 44087-3344 |