Prescription drug · ANDA
Baclofen (Intrathecal) (Baclofen) NDC 70511-122
Baclofen 500 ug/mL · Injection · Intrathecal · MAIA Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70511-122-10 | 7051101221070511012210 | 1 VIAL in 1 CARTON (70511-122-10) / 20 mL in 1 VIALMarketed from Sep 25, 2019 |
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 (Intrathecal)
- Generic name (nonproprietary)
- baclofen
- Active ingredients
- Baclofen — 500 ug/mL
- Dosage form
- Injection
- Route
- Intrathecal
- Labeler
- MAIA Pharmaceuticals, Inc.NDC labeler code 70511
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210048
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 70511-122_c15b60c7-4e21-4e28-898c-31e23052737aSPL ID c15b60c7-4e21-4e28-898c-31e23052737aSPL set ID 11ba5575-a856-414a-89f8-17f3a01de55bRxCUI 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
N470511012210followed by a unit qualifier and the quantityPackage 70511-0122-10. 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 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.
About NDC 70511-122
- What is NDC 70511-122?
- 70511-122 is the product NDC for Baclofen (Intrathecal) (baclofen), Baclofen 500 ug/mL injection, listed with the FDA by MAIA Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Baclofen (Intrathecal) (Baclofen).
- What is the active ingredient?
- Baclofen.
- Who is the labeler?
- MAIA Pharmaceuticals, Inc., NDC labeler code 70511. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Baclofen (Intrathecal)?
- 1 other product NDC are listed under this name. See all Baclofen (Intrathecal) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Baclofen (Intrathecal) products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Baclofen (Intrathecal)baclofen | Baclofen 2000 ug/mL | InjectionIntrathecal | MAIA Pharmaceuticals, Inc. | 70511-124 | 70511-0124-10 |
Other NDCs under ANDA 210048
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Baclofen | Baclofen 500 ug/mL | Injection, SolutionIntrathecal | Sagent Pharmaceuticals | 25021-678 |
| Baclofen | Baclofen 2000 ug/mL | Injection, SolutionIntrathecal | Sagent Pharmaceuticals | 25021-679 |
| Baclofen (Intrathecal)baclofen | Baclofen 2000 ug/mL | InjectionIntrathecal | MAIA Pharmaceuticals, Inc. | 70511-124 |