What is NDC 80425-0459?

80425-0459 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 80425-0459 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0459Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0459Add 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
80425-0459-1	8042504590180425045901	30 TABLET in 1 BOTTLE (80425-0459-1)Marketed from Dec 18, 2024
80425-0459-2	8042504590280425045902	60 TABLET in 1 BOTTLE (80425-0459-2)Marketed from Dec 18, 2024
80425-0459-3	8042504590380425045903	90 TABLET in 1 BOTTLE (80425-0459-3)Marketed from Dec 18, 2024
80425-0459-4	8042504590480425045904	120 TABLET in 1 BOTTLE (80425-0459-4)Marketed from Dec 18, 2024

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 212067
Marketing start: Dec 18, 2024
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 80425-0459_29a64de5-af3e-5a91-e063-6394a90ac35cSPL ID 29a64de5-af3e-5a91-e063-6394a90ac35cSPL set ID 29987a4c-cf5f-4f98-e063-6394a90a7f19RxCUI 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

N480425045901 followed by a unit qualifier and the quantity

Package 80425-0459-01. 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 19, 2024.

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 tablets 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 tablets in stroke, cerebral palsy, and Parkinson's disease has not been established and, th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0459

What is NDC 80425-0459?: 80425-0459 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 212067

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

FDA NDC Directory listings under ANDA 212067
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 10 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-343
Baclofen	Baclofen 20 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-344
Baclofen	Baclofen 5 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-474
Baclofen	Baclofen 10 mg/1	TabletOral	Redpharm Drug	67296-1947
Baclofen	Baclofen 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4162
Baclofen	Baclofen 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8783
Baclofen	Baclofen 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4249
Baclofen	Baclofen 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-2392
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-2756
Baclofen	Baclofen 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2448
Baclofen	Baclofen 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-2449
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	72162-2450
Baclofen	Baclofen 10 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0391
Baclofen	Baclofen 20 mg/1	TabletOral	PHOENIX RX LLC	85509-1344