What is NDC 58657-731?

58657-731 is the product NDC for Baclofen, Baclofen 10 mg/1 tablet, listed with the FDA by Method Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Method Pharmaceuticals LLC, NDC labeler code 58657. 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 58657-731 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58657-731Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58657-0731Add 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
58657-731-01	5865707310158657073101	100 TABLET in 1 BOTTLE (58657-731-01)Marketed from Jun 15, 2024
58657-731-10	5865707311058657073110	1000 TABLET in 1 BOTTLE (58657-731-10)Marketed from Jun 15, 2024
58657-731-50	5865707315058657073150	500 TABLET in 1 BOTTLE (58657-731-50)Marketed from Jun 15, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Method Pharmaceuticals LLCNDC labeler code 58657
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212378
Marketing start: Jun 15, 2024
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 58657-731_3aa113f3-27d5-328b-e063-6394a90af9e5SPL ID 3aa113f3-27d5-328b-e063-6394a90af9e5SPL set ID 1a9db542-d2b0-141a-e063-6394a90acc11RxCUI 197391, 197392, 430902UNII H789N3FKE8UPC 0358657731502, 0358657732509, 0358657931018, 0358657732011, 0358657932053, 0358657731106, 0358657931056, 0358657930011, 0358657732103, 0358657731014, 0358657930059, 0358657730017, 0358657932015, 0358657730109
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

N458657073101 followed by a unit qualifier and the quantity

Package 58657-0731-01. 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 Jul 23, 2025.

Indications (excerpt from the label)

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 not been established and, theref…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58657-731

What is NDC 58657-731?: 58657-731 is the product NDC for Baclofen, Baclofen 10 mg/1 tablet, listed with the FDA by Method Pharmaceuticals LLC. It has 3 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?: Method Pharmaceuticals LLC, NDC labeler code 58657. 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 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 10 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0156
Baclofen	Baclofen 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2372
Baclofen	Baclofen 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-2373
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	72162-2374
Baclofen	Baclofen 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-2826
Baclofen	Baclofen 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-3089
Baclofen	Baclofen 20 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0205
Baclofen	Baclofen 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-3115
Baclofen	Baclofen 5 mg/1	TabletOral	Method Pharmaceuticals LLC	58657-730
Baclofen	Baclofen 20 mg/1	TabletOral	Method Pharmaceuticals LLC	58657-732
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-1796
Baclofen	Baclofen 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-1797
Baclofen	Baclofen 10 mg/1	TabletOral	Bryant Ranch Prepack	63629-1224
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	63629-1225
Baclofen	Baclofen 20 mg/1	TabletOral	XLCare Pharmaceuticals Inc.	72865-298
Baclofen	Baclofen 5 mg/1	TabletOral	XLCare Pharmaceuticals Inc.	72865-296
Baclofen	Baclofen 10 mg/1	TabletOral	XLCare Pharmaceuticals Inc.	72865-297

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