Baclofen NDC 25021-680

NDC codes

FDA NDC Directory

Product NDC (as listed)25021-680Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25021-0680Add 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
25021-680-20	25021068020	1 VIAL in 1 CARTON (25021-680-20) / 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 — 1000 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 210315
Marketing start: Jul 15, 2021
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 25021-680_81266703-bafa-4e31-a400-32fbfe1a849eSPL ID 81266703-bafa-4e31-a400-32fbfe1a849eSPL set ID d4bfba33-9f4d-4c43-ae6c-bcf67ef8fe51RxCUI 1300890UNII 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

N425021068020 followed by a unit qualifier and the quantity

Package 25021-0680-20. 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 May 5, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. 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 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 i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210315

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

FDA NDC Directory listings under ANDA 210315
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 1000 ug/mL	InjectionIntrathecal	MAlA Pharmaceuticals, Inc.	70511-123