NDC codes

FDA NDC Directory
Product NDC (as listed)72888-146Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72888-0146Add 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
72888-146-3672888014636728880146361 VIAL, GLASS in 1 CARTON (72888-146-36) / 20 mL in 1 VIAL, GLASSMarketed from Feb 22, 2023

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
Route
Intrathecal
Labeler
Advagen Pharma LimitedNDC labeler code 72888
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217324
Marketing start
Listing expires
Other FDA classes
GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers
Product ID 72888-146_45801dc3-fb9b-c31e-e063-6294a90aff35SPL ID 45801dc3-fb9b-c31e-e063-6294a90aff35SPL set ID d63af5f0-c275-480b-89b5-6cf1ad55ab63RxCUI 308517, 1300890, 1666613UNII H789N3FKE8UPC 0372888147369, 0372888146362, 0372888145365
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

N472888014636 followed by a unit qualifier and the quantity

Package 72888-0146-36. 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)

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)

About NDC 72888-146

What is NDC 72888-146?
72888-146 is the product NDC for Baclofen, Baclofen 1000 ug/mL injection, listed with the FDA by Advagen Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Baclofen.
What is the active ingredient?
Baclofen.
Who is the labeler?
Advagen Pharma Limited, NDC labeler code 72888. 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?
219 other product NDCs are listed under this name. See all 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 Baclofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
BaclofenBaclofen 10 mg/5mLSolutionOralAcella Pharmaceuticals, LLC42192-63142192-0631-4042192-0631-45
BaclofenBaclofen 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-416268788-4162-0168788-4162-0368788-4162-06+2 more
BaclofenBaclofen 5 mg/1TabletOralREMEDYREPACK INC.70518-465670518-4656-00
BaclofenBaclofen 10 mg/1TabletOralCoupler LLC67046-107267046-1072-03
BaclofenBaclofen 20 mg/1TabletOralMedcore LLC82461-71882461-0718-10
BaclofenBaclofen 10 mg/1TabletOralMedcore LLC82461-71782461-0717-10
BaclofenBaclofen 10 mg/1TabletOralCardinal Health 107, LLC55154-019855154-0198-00
BaclofenBaclofen 10 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-056880425-0568-0180425-0568-0280425-0568-03+1 more
BaclofenBaclofen 20 mg/1TabletOralREMEDYREPACK INC.70518-453070518-4530-0070518-4530-01
BaclofenBaclofen 5 mg/1TabletOralAurobindo Pharma Limited84386-03584386-0035-01

All 220 Baclofen NDCs

Other NDCs under ANDA 217324

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

FDA NDC Directory listings under ANDA 217324
ProductStrengthForm · routeLabelerProduct NDC
BaclofenBaclofen 2000 ug/mLInjectionIntrathecalNexus Pharmaceuticals LLC14789-161
BaclofenBaclofen 500 ug/mLInjectionIntrathecalAdvagen Pharma Limited72888-145
BaclofenBaclofen 2000 ug/mLInjectionIntrathecalAdvagen Pharma Limited72888-147

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