Baclofen NDC 67544-671

NDC codes

FDA NDC Directory

Product NDC (as listed)67544-671Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67544-0671Add 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
67544-671-60	67544067160	90 TABLET in 1 BOTTLE, PLASTIC (67544-671-60)Marketed from Sep 14, 2006
67544-671-80	67544067180	180 TABLET in 1 BOTTLE, PLASTIC (67544-671-80)Marketed from Jul 28, 2008
67544-671-92	67544067192	270 TABLET in 1 BOTTLE, PLASTIC (67544-671-92)Marketed from Jul 28, 2008

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: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077156
Marketing start: Aug 30, 2005
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 67544-671_ba0a7c8f-e018-4e0b-97df-8e5752eb03adSPL ID ba0a7c8f-e018-4e0b-97df-8e5752eb03adSPL set ID dd4b9972-0295-4555-a90b-bb087170cfbbRxCUI 197391UNII 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

N467544067160 followed by a unit qualifier and the quantity

Package 67544-0671-60. 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 7, 2017.

Indications (excerpt from the label)

INDICATIONS AND USAGE Baclofen is 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 may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen is 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 not recommended for these c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077156

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

FDA NDC Directory listings under ANDA 077156
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-1152