Prescription drug · NDA
Gablofen (Baclofen injection) NDC 66794-151
Baclofen 50 ug/mL · Injection, Solution · Intrathecal · Piramal Critical Care Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66794-151-01 | 6679401510166794015101 | 1 mL in 1 SYRINGE, GLASS (66794-151-01)Marketed from Apr 1, 2017 |
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)
- Gablofen
- Generic name (nonproprietary)
- baclofen injection
- Active ingredients
- Baclofen — 50 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intrathecal
- Labeler
- Piramal Critical Care IncNDC labeler code 66794
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022462
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 66794-151_5135dfce-e3c4-a382-e063-6394a90a4875SPL ID 5135dfce-e3c4-a382-e063-6394a90a4875SPL set ID 00d3e846-dd92-448d-9ab8-6a07be823cc1RxCUI 308517, 1047437, 1047440, 1047444, 1300890, 1301627, 1369783, 1369784, 1369787, 1369788, 1369791, 1369792, 1666613, 1666615UNII H789N3FKE8UPC 0366794157024, 0366794155020, 0366794156027
- Pharmacologic class
- gamma-Aminobutyric Acid-ergic 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.
- NDC on a medical claim
N466794015101followed by a unit qualifier and the quantityPackage 66794-0151-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
GABLOFEN is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of GABLOFEN via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. GABLOFEN is intended for use b…
Excerpt only. Read the full label for complete information.
About NDC 66794-151
- What is NDC 66794-151?
- 66794-151 is the product NDC for Gablofen (baclofen injection), Baclofen 50 ug/mL injection, solution, listed with the FDA by Piramal Critical Care Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gablofen (Baclofen Injection).
- What is the active ingredient?
- Baclofen.
- Who is the labeler?
- Piramal Critical Care Inc, NDC labeler code 66794. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gablofen?
- 3 other product NDCs are listed under this name. See all Gablofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gablofen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gablofenbaclofen injection | Baclofen 500 ug/mL | Injection, SolutionIntrathecal | Piramal Critical Care Inc | 66794-155 | 66794-0155-0166794-0155-02 |
| Gablofenbaclofen injection | Baclofen 1000 ug/mL | Injection, SolutionIntrathecal | Piramal Critical Care Inc | 66794-156 | 66794-0156-0166794-0156-02 |
| Gablofenbaclofen injection | Baclofen 2000 ug/mL | Injection, SolutionIntrathecal | Piramal Critical Care Inc | 66794-157 | 66794-0157-0166794-0157-02 |
Other NDCs under NDA 022462
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 |
|---|---|---|---|---|
| Gablofenbaclofen injection | Baclofen 500 ug/mL | Injection, SolutionIntrathecal | Piramal Critical Care Inc | 66794-155 |
| Gablofenbaclofen injection | Baclofen 1000 ug/mL | Injection, SolutionIntrathecal | Piramal Critical Care Inc | 66794-156 |
| Gablofenbaclofen injection | Baclofen 2000 ug/mL | Injection, SolutionIntrathecal | Piramal Critical Care Inc | 66794-157 |