Prescription drug · BLA
Follistim AQ (follitropin) NDC 78206-131
Follitropin 900 [iU]/1.08mL · Injection, Solution · Subcutaneous · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-131-01 | 78206013101 | 1 KIT in 1 CARTON (78206-131-01) / 1 CARTRIDGE in 1 KIT / 1.08 mL in 1 CARTRIDGE (78206-131-99)Marketed from Jul 24, 2023 |
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)
- Follistim AQ
- Generic name (nonproprietary)
- follitropin
- Active ingredients
- Follitropin — 900 [iU]/1.08mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Organon LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 021211
- Marketing start
- Listing expires
- Other FDA classes
- Gonadotropins (Chemical structure)
- Identifiers
- Product ID 78206-131_1156138e-9093-46b4-aa5b-9b88e72d1790SPL ID 1156138e-9093-46b4-aa5b-9b88e72d1790SPL set ID 48489027-e52b-4b10-ae74-4ba03839150cRxCUI 854787, 854788, 854790, 1361563, 1361569, 1361572UNII 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
N478206013101followed by a unit qualifier and the quantityPackage 78206-0131-01. 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)
FOLLISTIM ® AQ Cartridge (follitropin beta) injection, is indicated: In Women for: FOLLISTIM AQ Cartridge is a gonadotropin indicated: In Women for: Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure ( 1.1 ) Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle ( 1.2 ) In Men for: Induction of Spermatogenesis in Men with Primary and Secondary Hypogonadotropic Hypogonadism (HH) in Whom the Cause of Infertility is Not Due to Primary Testicular Failure ( 1.3 ) 1.1 Induction of Ov…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 021211
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 |
|---|---|---|---|---|
| Follistim AQfollitropin | Follitropin 300 [iU]/.36mL | Injection, SolutionSubcutaneous | Organon LLC | 78206-129 |
| Follistim AQfollitropin | Follitropin 600 [iU]/.72mL | Injection, SolutionSubcutaneous | Organon LLC | 78206-130 |