Baclofen NDC 71225-140

NDC codes

FDA NDC Directory

Product NDC (as listed)71225-140Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71225-0140Add 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
71225-140-01	71225014001	1 BOTTLE in 1 CARTON (71225-140-01) / 250 mL in 1 BOTTLEMarketed from Jun 19, 2023

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 — 5 mg/mL
Dosage form: Suspension
Route: Oral
Labeler: Slayback Pharma LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217252
Marketing start: Jun 19, 2023
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 71225-140_f948e217-c9bb-4ec1-b5fb-864cc14afe4eSPL ID f948e217-c9bb-4ec1-b5fb-864cc14afe4eSPL set ID 9fad5ffc-afae-4c92-a672-ee636df45bc5RxCUI 2593376UNII 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

N471225014001 followed by a unit qualifier and the quantity

Package 71225-0140-01. 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 Jun 16, 2023.

Indications (excerpt from the label)

Baclofen oral suspension 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 suspension may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen oral suspension is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. • Baclofen oral suspension 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 musc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217252

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

FDA NDC Directory listings under ANDA 217252
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 5 mg/mL	SuspensionOral	ANI Pharmaceuticals, Inc.	62559-204