Baclofen NDC 25021-679

NDC codes

FDA NDC Directory

Product NDC (as listed)25021-679Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25021-0679Add 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
25021-679-20	25021067920	1 VIAL in 1 CARTON (25021-679-20) / 20 mL in 1 VIALMarketed from Jul 15, 2021

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 — 2000 ug/mL
Dosage form: Injection, Solution
Route: Intrathecal
Labeler: Sagent Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210048
Marketing start: Jul 15, 2021
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 25021-679_9ae563da-240a-468d-bc42-ed4667df2392SPL ID 9ae563da-240a-468d-bc42-ed4667df2392SPL set ID 077aaf3b-1ca3-4599-a51a-6bbe39810ca8RxCUI 308517, 1666613UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N425021067920 followed by a unit qualifier and the quantity

Package 25021-0679-20. 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 24, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Baclofen injection (intrathecal) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection (intrathecal) via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Baclofen injec…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210048

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

FDA NDC Directory listings under ANDA 210048
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 500 ug/mL	Injection, SolutionIntrathecal	Sagent Pharmaceuticals	25021-678
Baclofen (Intrathecal)baclofen	Baclofen 500 ug/mL	InjectionIntrathecal	MAIA Pharmaceuticals, Inc.	70511-122
Baclofen (Intrathecal)baclofen	Baclofen 2000 ug/mL	InjectionIntrathecal	MAIA Pharmaceuticals, Inc.	70511-124