Prescription drug · NDA
Supprelin LA (Histrelin acetate) NDC 67979-002
Histrelin acetate 50 mg/1 · Implant · Subcutaneous · Endo USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67979-002-01 | 6797900020167979000201 | 1 VIAL, GLASS in 1 CARTON (67979-002-01) / 1 IMPLANT in 1 VIAL, GLASSMarketed from May 31, 2007 |
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)
- Supprelin LASuffix: LA
- Generic name (nonproprietary)
- histrelin acetate
- Active ingredients
- Histrelin acetate — 50 mg/1
- Dosage form
- Implant
- Route
- Subcutaneous
- Labeler
- Endo USA, Inc.NDC labeler code 67979
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022058
- Marketing start
- Listing expires
- Other FDA classes
- Gonadotropin Releasing Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 67979-002_917e915f-4793-48bf-84c3-50272421616fSPL ID 917e915f-4793-48bf-84c3-50272421616fSPL set ID d8fb000e-3cc9-4803-b71d-2cc597661977RxCUI 1294641, 1740437UNII QMG7HLD1ZEUPC 0367979002016
- Pharmacologic class
- Gonadotropin Releasing Hormone Receptor Agonist
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
N467979000201followed by a unit qualifier and the quantityPackage 67979-0002-01. 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)
SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chrono…
Excerpt only. Read the full label for complete information.
About NDC 67979-002
- What is NDC 67979-002?
- 67979-002 is the product NDC for Supprelin LA (histrelin acetate), Histrelin acetate 50 mg/1 implant, listed with the FDA by Endo USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Supprelin LA (Histrelin acetate).
- What is the active ingredient?
- Histrelin acetate.
- Who is the labeler?
- Endo USA, Inc., NDC labeler code 67979. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Supprelin LA?
- 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.