Baclofen NDC 80425-0080

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0080Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0080Add 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
80425-0080-2	80425008002	60 TABLET in 1 BOTTLE (80425-0080-2)Marketed from Jul 21, 1988
80425-0080-3	80425008003	90 TABLET in 1 BOTTLE (80425-0080-3)Marketed from Jul 21, 1988

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Baclofen
Generic name (nonproprietary): baclofen
Active ingredients: Baclofen — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072234
Marketing start: Jul 21, 1988
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 80425-0080_2a9914d0-6557-747c-e063-6294a90a946cSPL ID 2a9914d0-6557-747c-e063-6294a90a946cSPL set ID b33c4164-e607-2e27-e053-2a95a90ad7dbRxCUI 197391UNII H789N3FKE8
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480425008002 followed by a unit qualifier and the quantity

Package 80425-0080-02. 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 Dec 31, 2024.

Indications (excerpt from the label)

3. Indications and Usage Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 072234

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

FDA NDC Directory listings under ANDA 072234
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 10 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0172-4096
Baclofen	Baclofen 10 mg/1	TabletOral	Northwind Health Company, LLC	82868-013
Baclofen	Baclofen 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	55289-757
Baclofen	Baclofen 10 mg/1	TabletOral	Proficient Rx LP	63187-147