Prescription drug · NDA

Lioresal (baclofen) (Baclofen) NDC 70121-2505

Kit · Intrathecal · Amneal Pharmaceuticals LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)70121-2505Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70121-2505Add 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 NDC11-digit (billing)PackageCopy
70121-2505-270121250502701212505022 AMPULE in 1 BOX (70121-2505-2) / 1 KIT in 1 AMPULEMarketed from Jun 12, 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)
Lioresal (baclofen)
Generic name (nonproprietary)
baclofen
Dosage form
Kit
Route
Intrathecal
Labeler
Amneal Pharmaceuticals LLCNDC labeler code 70121
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020075
Marketing start
Listing expires
Identifiers
Product ID 70121-2505_d68a08e0-d0d9-4144-be01-47b636dfa7e1SPL ID d68a08e0-d0d9-4144-be01-47b636dfa7e1SPL set ID 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5RxCUI 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 1666623UNII H789N3FKE8UPC 0370121250319, 0370121250524, 0370121250227, 0370121250425, 0370121250111

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

N470121250502 followed by a unit qualifier and the quantity

Package 70121-2505-02. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE LIORESAL INTRATHECAL (baclofen injection) 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 LIORESAL 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. LIORESAL INTRATHE…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70121-2505

What is NDC 70121-2505?
70121-2505 is the product NDC for Lioresal (baclofen) (baclofen) kit, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Lioresal (baclofen) (Baclofen).
Who is the labeler?
Amneal Pharmaceuticals LLC, NDC labeler code 70121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lioresal (baclofen)?
5 other product NDCs are listed under this name. See all Lioresal (baclofen) NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lioresal (baclofen) NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Lioresal (baclofen)baclofenBaclofen .05 mg/mLInjectionIntrathecalAmneal Pharmaceuticals LLC70121-249670121-2496-05
Lioresal (baclofen)baclofen—KitIntrathecalAmneal Pharmaceuticals LLC70121-250170121-2501-01
Lioresal (baclofen)baclofen—KitIntrathecalAmneal Pharmaceuticals LLC70121-250270121-2502-02
Lioresal (baclofen)baclofen—KitIntrathecalAmneal Pharmaceuticals LLC70121-250370121-2503-01
Lioresal (baclofen)baclofen—KitIntrathecalAmneal Pharmaceuticals LLC70121-250470121-2504-02

Other NDCs under NDA 020075

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

FDA NDC Directory listings under NDA 020075
ProductStrengthForm · routeLabelerProduct NDC
Lioresal (baclofen)baclofenBaclofen .05 mg/mLInjectionIntrathecalAmneal Pharmaceuticals LLC70121-2496
Lioresal (baclofen)baclofen—KitIntrathecalAmneal Pharmaceuticals LLC70121-2501
Lioresal (baclofen)baclofen—KitIntrathecalAmneal Pharmaceuticals LLC70121-2502
Lioresal (baclofen)baclofen—KitIntrathecalAmneal Pharmaceuticals LLC70121-2503
Lioresal (baclofen)baclofen—KitIntrathecalAmneal Pharmaceuticals LLC70121-2504

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