Prescription drug · BLA
Gonal-f RFF Redi-ject (Follitropin) NDC 44087-1116
Follitropin 450 [iU]/.75mL · Injection, Solution · Subcutaneous · EMD Serono, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44087-1116-1 | 4408711160144087111601 | 1 PACKAGE in 1 CARTON (44087-1116-1) / .75 mL in 1 PACKAGEMarketed from Oct 16, 2013 |
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)
- Gonal-f RFF Redi-ject
- Generic name (nonproprietary)
- follitropin
- Active ingredients
- Follitropin — 450 [iU]/.75mL
- 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 021684
- Marketing start
- Listing expires
- Other FDA classes
- Gonadotropins (Chemical structure)
- Identifiers
- Product ID 44087-1116_657d712c-ea55-4e2b-9111-ed8dc792887bSPL ID 657d712c-ea55-4e2b-9111-ed8dc792887bSPL set ID b6d11c45-b502-478e-bb28-2ff596ea259cRxCUI 1594334, 1594418, 1594432, 1654171, 1654179, 1654184UNII 076WHW89TW
- Pharmacologic class
- Gonadotropin
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
N444087111601followed by a unit qualifier and the quantityPackage 44087-1116-01. 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)
GONAL-f ® RFF Redi-ject ® is a prefilled gonadotropin-containing auto-injection device indicated for: Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure ( 1.1 ) Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle ( 1.2 ) 1.1 Induction of Ovulation and Pregnancy in Oligo-Anovulatory Women in whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure. Prior to initiation of treatment with GONAL-f ® RFF Redi-ject ® : Perform a complete gynecologic and endocrinologic evaluation Exclude primary ovarian failure Exclud…
Excerpt only. Read the full label for complete information.
About NDC 44087-1116
- What is NDC 44087-1116?
- 44087-1116 is the product NDC for Gonal-f RFF Redi-ject (follitropin), Follitropin 450 [iU]/.75mL 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?
- Gonal-f RFF Redi-ject (Follitropin).
- What is the active ingredient?
- Follitropin.
- 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 Gonal-f RFF Redi-ject?
- 2 other product NDCs are listed under this name. See all Gonal-f RFF Redi-ject NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gonal-f RFF Redi-ject products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gonal-f RFF Redi-jectfollitropin | Follitropin 300 [iU]/.5mL | Injection, SolutionSubcutaneous | EMD Serono, Inc. | 44087-1115 | 44087-1115-01 |
| Gonal-f RFF Redi-jectfollitropin | Follitropin 900 [iU]/1.5mL | Injection, SolutionSubcutaneous | EMD Serono, Inc. | 44087-1117 | 44087-1117-01 |
Other NDCs under BLA 021684
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 |
|---|---|---|---|---|
| Gonal-f RFF Redi-jectfollitropin | Follitropin 300 [iU]/.5mL | Injection, SolutionSubcutaneous | EMD Serono, Inc. | 44087-1115 |
| Gonal-f RFF Redi-jectfollitropin | Follitropin 900 [iU]/1.5mL | Injection, SolutionSubcutaneous | EMD Serono, Inc. | 44087-1117 |