Baclofen NDC 80425-0156

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0156Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0156Add 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
80425-0156-1	80425015601	30 TABLET in 1 BOTTLE (80425-0156-1)Marketed from Oct 9, 2020
80425-0156-2	80425015602	60 TABLET in 1 BOTTLE (80425-0156-2)Marketed from Oct 9, 2020
80425-0156-3	80425015603	90 TABLET in 1 BOTTLE (80425-0156-3)Marketed from Oct 9, 2020
80425-0156-4	80425015604	120 TABLET in 1 BOTTLE (80425-0156-4)Marketed from May 18, 2023

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 Pharmacy of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212378
Marketing start: Oct 9, 2020
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 80425-0156_2a99a7c1-c4c2-2b01-e063-6294a90aa3b8SPL ID 2a99a7c1-c4c2-2b01-e063-6294a90aa3b8SPL set ID c85a1884-f46f-5cd4-e053-2a95a90a3e27RxCUI 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

N480425015601 followed by a unit qualifier and the quantity

Package 80425-0156-01. 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 Dec 31, 2024.

Indications (excerpt from the label)

Indications and Usage Section INDICATIONS AND USAGE Baclofen tablets USP 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 USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP 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 no…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212378

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

FDA NDC Directory listings under ANDA 212378
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-3115
Baclofen	Baclofen 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-1797
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-1796
Baclofen	Baclofen 20 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0205
Baclofen	Baclofen 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-3089
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-2668
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-2669
Baclofen	Baclofen 5 mg/1	TabletOral	Method Pharmaceuticals LLC	58657-730
Baclofen	Baclofen 10 mg/1	TabletOral	Method Pharmaceuticals LLC	58657-731
Baclofen	Baclofen 20 mg/1	TabletOral	Method Pharmaceuticals LLC	58657-732
Baclofen	Baclofen 10 mg/1	TabletOral	Bryant Ranch Prepack	63629-1225
Baclofen	Baclofen 20 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0282
Baclofen	Baclofen 5 mg/1	TabletOral	Method Pharmaceuticals LLC	58657-930
Baclofen	Baclofen 10 mg/1	TabletOral	Method Pharmaceuticals LLC	58657-931
Baclofen	Baclofen 20 mg/1	TabletOral	Method Pharmaceuticals LLC	58657-932
Baclofen	Baclofen 10 mg/1	TabletOral	Bryant Ranch Prepack	63629-1224
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	63629-1227
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	63629-1228
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-2482
Baclofen	Baclofen 10 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-660

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