What is NDC 80425-0478?

80425-0478 is the product NDC for Baclofen, Baclofen 20 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Baclofen?

219 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Baclofen NDC 80425-0478 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0478Add 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
80425-0478-1	8042504780180425047801	30 TABLET in 1 BOTTLE (80425-0478-1)Marketed from Jan 30, 2025
80425-0478-2	8042504780280425047802	60 TABLET in 1 BOTTLE (80425-0478-2)Marketed from Jan 30, 2025
80425-0478-3	8042504780380425047803	90 TABLET in 1 BOTTLE (80425-0478-3)Marketed from Jan 30, 2025
80425-0478-4	8042504780480425047804	120 TABLET in 1 BOTTLE (80425-0478-4)Marketed from Jan 30, 2025

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 — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214374
Marketing start: Jan 30, 2025
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 80425-0478_2cf6fc95-e6ff-0af3-e063-6294a90ac508SPL ID 2cf6fc95-e6ff-0af3-e063-6294a90ac508SPL set ID 2cf71f5f-6d46-7506-e063-6294a90a186fRxCUI 197392UNII 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

N480425047801 followed by a unit qualifier and the quantity

Package 80425-0478-01. 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 Jan 30, 2025.

Indications (excerpt from the label)

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, USP 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0478

What is NDC 80425-0478?: 80425-0478 is the product NDC for Baclofen, Baclofen 20 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Baclofen.
What is the active ingredient?: Baclofen.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Baclofen?: 219 other product NDCs are listed under this name. See all Baclofen NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Baclofen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Baclofen	Baclofen 10 mg/5mL	SolutionOral	Acella Pharmaceuticals, LLC	42192-631	42192-0631-4042192-0631-45
Baclofen	Baclofen 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4162	68788-4162-0168788-4162-0368788-4162-06+2 more
Baclofen	Baclofen 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4656	70518-4656-00
Baclofen	Baclofen 10 mg/1	TabletOral	Coupler LLC	67046-1072	67046-1072-03
Baclofen	Baclofen 20 mg/1	TabletOral	Medcore LLC	82461-718	82461-0718-10
Baclofen	Baclofen 10 mg/1	TabletOral	Medcore LLC	82461-717	82461-0717-10
Baclofen	Baclofen 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0198	55154-0198-00
Baclofen	Baclofen 10 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0568	80425-0568-0180425-0568-0280425-0568-03+1 more
Baclofen	Baclofen 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4530	70518-4530-0070518-4530-01
Baclofen	Baclofen 5 mg/1	TabletOral	Aurobindo Pharma Limited	84386-035	84386-0035-01

All 220 Baclofen NDCs

Other NDCs under ANDA 214374

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

FDA NDC Directory listings under ANDA 214374
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 5 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-169
Baclofen	Baclofen 10 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-171
Baclofen	Baclofen 20 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-172
Baclofen	Baclofen 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3700
Baclofen	Baclofen 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-5327
Baclofen	Baclofen 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8726
Baclofen	Baclofen 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8737
Baclofen	Baclofen 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4235
Baclofen	Baclofen 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4384
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-2497
Baclofen	Baclofen 5 mg/1	TabletOral	Bryant Ranch Prepack	71335-3050
Baclofen	Baclofen 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-9759
Baclofen	Baclofen 20 mg/1	TabletOral	Direct_rx	72189-565