Gablofen (baclofen injection) NDC 66794-157

NDC codes

FDA NDC Directory

Product NDC (as listed)66794-157Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66794-0157Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
66794-157-01	66794015701	20 mL in 1 SYRINGE, GLASS (66794-157-01)Marketed from Apr 1, 2017
66794-157-02	66794015702	20 mL in 1 VIAL, GLASS (66794-157-02)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 — 2000 ug/mL
Dosage form: Injection, Solution
Route: Intrathecal
Labeler: Piramal Critical Care Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022462
Marketing start: Apr 1, 2017
Listing expires: Dec 31, 2027
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 66794-157_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

N466794015701 followed by a unit qualifier and the quantity

Package 66794-0157-01. 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 May 7, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022462

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022462
Product	Strength	Form · route	Labeler	Product NDC
Gablofenbaclofen injection	Baclofen 50 ug/mL	Injection, SolutionIntrathecal	Piramal Critical Care Inc	66794-151
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