What is NDC 42192-631?

42192-631 is the product NDC for Baclofen, Baclofen 10 mg/5mL solution, listed with the FDA by Acella Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Acella Pharmaceuticals, LLC, NDC labeler code 42192. 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 42192-631 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42192-631Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42192-0631Add 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
42192-631-40	4219206314042192063140	40 CUP, UNIT-DOSE in 1 CASE (42192-631-40) / 10 mL in 1 CUP, UNIT-DOSE (42192-631-10)Marketed from Oct 26, 2026
42192-631-45	4219206314542192063145	40 CUP, UNIT-DOSE in 1 CASE (42192-631-45) / 5 mL in 1 CUP, UNIT-DOSE (42192-631-05)Marketed from Oct 26, 2026

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/5mL
Dosage form: Solution
Route: Oral
Labeler: Acella Pharmaceuticals, LLCNDC labeler code 42192
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208193
Marketing start: Oct 26, 2026
Listing expires: Dec 31, 2027
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 42192-631_5d57932e-eed9-096d-e063-6294a90a1c19SPL ID 5d57932e-eed9-096d-e063-6294a90a1c19SPL set ID 231ef477-822c-46fe-9bf3-d55cdf9bd4c2RxCUI 2667941UNII 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

N442192063140 followed by a unit qualifier and the quantity

Package 42192-0631-40. 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 8, 2026.

Indications (excerpt from the label)

Baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. Baclofen oral solution is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigid…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42192-631

What is NDC 42192-631?: 42192-631 is the product NDC for Baclofen, Baclofen 10 mg/5mL solution, listed with the FDA by Acella Pharmaceuticals, LLC. 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?: Acella Pharmaceuticals, LLC, NDC labeler code 42192. 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 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
Baclofen	Baclofen 10 mg/1	TabletOral	Major Pharmaceuticals	0904-7552	00904-7552-61

All 220 Baclofen NDCs

Other NDCs under NDA 208193

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

FDA NDC Directory listings under NDA 208193
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 10 mg/5mL	SolutionOral	Atlantic Biologicals Corp.	17856-0620
Baclofen	Baclofen 10 mg/5mL	SolutionOral	TRUPHARMA, LLC	52817-620
Baclofen	Baclofen 10 mg/5mL	SolutionOral	Palmetto Pharmaceuticals Inc.	68134-403
Ozobax Dsbaclofen	Baclofen 10 mg/5mL	SolutionOral	Rosemont Pharmaceuticals LLC	69528-302