Fleqsuvy (baclofen) NDC 52652-6001

NDC codes

FDA NDC Directory

Product NDC (as listed)52652-6001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52652-6001Add 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
52652-6001-1	52652600101	1 BOTTLE in 1 CARTON (52652-6001-1) / 120 mL in 1 BOTTLEMarketed from Feb 7, 2022
52652-6001-2	52652600102	1 BOTTLE in 1 CARTON (52652-6001-2) / 300 mL in 1 BOTTLEMarketed from Feb 7, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Fleqsuvy
Generic name (nonproprietary): baclofen
Active ingredients: Baclofen — 5 mg/mL
Dosage form: Suspension
Route: Oral
Labeler: Azurity Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215602
Marketing start: Feb 7, 2022
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 52652-6001_461e773b-ccc2-532d-e063-6294a90abad9SPL ID 461e773b-ccc2-532d-e063-6294a90abad9SPL set ID 9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aaRxCUI 2593376, 2593382UNII 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

N452652600101 followed by a unit qualifier and the quantity

Package 52652-6001-01. 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 Dec 16, 2025.

Indications (excerpt from the label)

FLEQSUVY 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. FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. FLEQSUVY 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 rigidity. ( 1 ) FLEQSUVY may also be of some value in patient…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 215602

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

FDA NDC Directory listings under NDA 215602
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 5 mg/mL	SuspensionOral	Wilshire Pharmaceuticals, Inc.	52536-600