Baclofen NDC 71610-446

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-446Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0446Add 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
71610-446-45	71610044645	45 TABLET in 1 BOTTLE (71610-446-45)Marketed from Jul 21, 2020
71610-446-60	71610044660	90 TABLET in 1 BOTTLE (71610-446-60)Marketed from Jul 21, 2020
71610-446-92	71610044692	270 TABLET in 1 BOTTLE (71610-446-92)Marketed from Jul 30, 2020

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 — 20 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 078401
Marketing start: Jan 1, 2011
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 71610-446_edf4b7c6-f843-4177-ba85-410ad266ba81SPL ID edf4b7c6-f843-4177-ba85-410ad266ba81SPL set ID 9edc00c6-c281-4e81-b176-44b7536f71f2RxCUI 197392UNII 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

N471610044645 followed by a unit qualifier and the quantity

Package 71610-0446-45. 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 Aug 13, 2020.

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)

Other NDCs under ANDA 078401

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

FDA NDC Directory listings under ANDA 078401
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 10 mg/1	TabletOral	A-S Medication Solutions	50090-7913
Baclofen	Baclofen 20 mg/1	TabletOral	Northstar RxLLC	16714-072
Baclofen	Baclofen 10 mg/1	TabletOral	Northstar RxLLC	16714-071
Baclofen	Baclofen 20 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0081