What is NDC 55289-757?

55289-757 is the product NDC for Baclofen, Baclofen 10 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

PD-Rx Pharmaceuticals, Inc., NDC labeler code 55289. 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 55289-757 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55289-757Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55289-0757Add 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
55289-757-30	5528907573055289075730	30 TABLET in 1 BOTTLE, PLASTIC (55289-757-30)Marketed from Mar 24, 2009
55289-757-60	5528907576055289075760	60 TABLET in 1 BOTTLE, PLASTIC (55289-757-60)Marketed from Mar 24, 2009
55289-757-90	5528907579055289075790	90 TABLET in 1 BOTTLE, PLASTIC (55289-757-90)Marketed from Dec 26, 2007

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: PD-Rx Pharmaceuticals, Inc.NDC labeler code 55289
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072234
Marketing start: Jul 21, 1988
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 55289-757_419b4e87-cb86-8fbc-e063-6394a90a3b7cSPL ID 419b4e87-cb86-8fbc-e063-6394a90a3b7cSPL set ID 95755a7b-4a9f-45ea-a381-d3f661150efeRxCUI 197391UNII H789N3FKE8UPC 0355289757306
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

N455289075730 followed by a unit qualifier and the quantity

Package 55289-0757-30. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 55289-757

What is NDC 55289-757?: 55289-757 is the product NDC for Baclofen, Baclofen 10 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. 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?: PD-Rx Pharmaceuticals, Inc., NDC labeler code 55289. 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 072234

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

FDA NDC Directory listings under ANDA 072234
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 10 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0172-4096
Baclofen	Baclofen 10 mg/1	TabletOral	Proficient Rx LP	63187-147
Baclofen	Baclofen 10 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0080
Baclofen	Baclofen 10 mg/1	TabletOral	Northwind Health Company, LLC	82868-013