Gablofen Injection, Solution
NDC Package 66794-151-01
Package Information
Gablofen (baclofen injection) injection is baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, cerebral palsy, spinal cord injury/disease). This formulation utilizes a injection, solution delivery system. Marketed by Piramal Critical Care Inc, this product is identified by NDC 66794-151 and is authorized under FDA application NDA022462.
Identification & Billing
- RxCUI: 1047437 - baclofen 50 MCG in 1 ML Prefilled Syringe
- RxCUI: 1047437 - 1 ML baclofen 0.05 MG/ML Prefilled Syringe
- RxCUI: 1047437 - baclofen 50 MCG per 1 ML Prefilled Syringe
- RxCUI: 1047440 - Gablofen 50 MCG in 1 ML Prefilled Syringe
- RxCUI: 1047440 - 1 ML baclofen 0.05 MG/ML Prefilled Syringe [Gablofen]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 66794 - Piramal Critical Care Inc
- 66794-151 - Gablofen
- 66794-151-01 - 1 mL in 1 SYRINGE, GLASS
- 66794-151 - Gablofen
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 66794-151-01 identifies a specific commercial package of 1 ml in 1 syringe, glass of Gablofen, a human prescription drug labeled by Piramal Critical Care Inc. This product is billed per "ML" milliliter and contains an estimated amount of 1 billable units per package. This injection, solution is formulated for intrathecal use and contains baclofen as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Piramal Critical Care Inc on April 01, 2017. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, cerebral palsy, spinal cord injury/disease). It works by helping to relax the muscles. Baclofen injection is used by patients who do not respond to or who cannot tolerate the side effects of baclofen taken by mouth.
How is this Piramal Critical Care Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 66794015101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
