What is NDC 0615-8518?

0615-8518 is the product NDC for Baclofen, Baclofen 5 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 0615-8518 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8518Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8518Add 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
0615-8518-05	0061585180500615851805	15 TABLET in 1 BLISTER PACK (0615-8518-05)Marketed from Aug 14, 2024
0615-8518-39	0061585183900615851839	30 TABLET in 1 BLISTER PACK (0615-8518-39)Marketed from Aug 14, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215885
Marketing start: Jan 26, 2022
Listing expires: Dec 31, 2027
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 0615-8518_8c1dfdbe-e30f-436d-882e-8b4c5f8ca29aSPL ID 8c1dfdbe-e30f-436d-882e-8b4c5f8ca29aSPL set ID ea4ad5c5-207c-4a68-8e6e-4ff101777e5cRxCUI 430902UNII 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

N400615851805 followed by a unit qualifier and the quantity

Package 00615-8518-05. 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 Oct 4, 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 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 is n…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8518

What is NDC 0615-8518?: 0615-8518 is the product NDC for Baclofen, Baclofen 5 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 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?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 215885

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

FDA NDC Directory listings under ANDA 215885
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 10 mg/1	TabletOral	Major Pharmaceuticals	0904-7552
Baclofen	Baclofen 20 mg/1	TabletOral	Major Pharmaceuticals	0904-7553
Baclofen	Baclofen 5 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-972
Baclofen	Baclofen 10 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-973
Baclofen	Baclofen 20 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-974
Baclofen	Baclofen 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0198
Baclofen	Baclofen 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4378
Baclofen	Baclofen 5 mg/1	TabletOral	Lifestar Pharma LLC	70756-085
Baclofen	Baclofen 10 mg/1	TabletOral	Lifestar Pharma LLC	70756-288
Baclofen	Baclofen 20 mg/1	TabletOral	Lifestar Pharma LLC	70756-289
Baclofen	Baclofen 20 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-921
Baclofen	Baclofen 10 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-924