Prescription drug · ANDA

Baclofen NDC 55154-0582

Baclofen 5 mg/1 · Tablet · Oral · Cardinal Health 107, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)55154-0582Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-0582Add 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
55154-0582-0551540582005515405820010 BLISTER PACK in 1 BAG (55154-0582-0) / 1 TABLET in 1 BLISTER PACKMarketed from Nov 6, 2026

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)
Baclofen
Generic name (nonproprietary)
baclofen
Active ingredients
Baclofen — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Cardinal Health 107, LLCNDC labeler code 55154
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209102
Marketing start
Listing expires
Other FDA classes
GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers
Product ID 55154-0582_53200412-7d41-406d-b897-edeaab5f9078SPL ID 53200412-7d41-406d-b897-edeaab5f9078
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N455154058200 followed by a unit qualifier and the quantity

Package 55154-0582-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 55154-0582

What is NDC 55154-0582?
55154-0582 is the product NDC for Baclofen, Baclofen 5 mg/1 tablet, listed with the FDA by Cardinal Health 107, LLC. 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?
Cardinal Health 107, LLC, NDC labeler code 55154. 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?
221 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 5 mg/mLSuspensionOralAvPAK50268-12050268-0120-12
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 10 mg/1TabletOralMedcore LLC82461-71782461-0717-10
BaclofenBaclofen 20 mg/1TabletOralMedcore LLC82461-71882461-0718-10
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

All 222 Baclofen NDCs

Other NDCs under ANDA 209102

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

FDA NDC Directory listings under ANDA 209102
ProductStrengthForm · routeLabelerProduct NDC
BaclofenBaclofen 10 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8466
BaclofenBaclofen 20 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8467
BaclofenBaclofen 5 mg/1TabletOralMajor Pharmaceuticals0904-7558
BaclofenBaclofen 10 mg/1TabletOralA-S Medication Solutions50090-7600
BaclofenBaclofen 10 mg/1TabletOralA-S Medication Solutions50090-7601
BaclofenBaclofen 15 mg/1TabletOralTruPharma LLC52817-318
BaclofenBaclofen 5 mg/1TabletOralTruPharma LLC52817-319
BaclofenBaclofen 10 mg/1TabletOralTruPharma LLC52817-320
BaclofenBaclofen 20 mg/1TabletOralTruPharma LLC52817-321
BaclofenBaclofen 10 mg/1TabletOralRedpharm Drug67296-2259
BaclofenBaclofen 10 mg/1TabletOralSOLA Pharmaceuticals, LLC70512-782
BaclofenBaclofen 10 mg/1TabletOralREMEDYREPACK INC.70518-3614
BaclofenBaclofen 20 mg/1TabletOralREMEDYREPACK INC.70518-4290
BaclofenBaclofen 20 mg/1TabletOralREMEDYREPACK INC.70518-4530
BaclofenBaclofen 5 mg/1TabletOralREMEDYREPACK INC.70518-4656
BaclofenBaclofen 20 mg/1TabletOralBryant Ranch Prepack71335-0949
BaclofenBaclofen 10 mg/1TabletOralBryant Ranch Prepack71335-9638
BaclofenBaclofen 20 mg/1TabletOralDirect_Rx72189-504
BaclofenBaclofen 20 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-312
BaclofenBaclofen 5 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-478

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