NDC codes

FDA NDC Directory
Product NDC (as listed)55154-7876Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-7876Add 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
55154-7876-0551547876005515478760010 BLISTER PACK in 1 BAG (55154-7876-0) / 1 TABLET in 1 BLISTER PACKMarketed from Jul 15, 2015

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 — 20 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 077241
Marketing start
Marketing end
Other FDA classes
GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers
Product ID 55154-7876_ee805abe-f897-47f7-a472-9630a160d0c1SPL ID ee805abe-f897-47f7-a472-9630a160d0c1SPL set ID 2278954a-7605-426a-ae85-1bf0a3117420RxCUI 197391, 197392UNII H789N3FKE8UPC 0055154763509
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

N455154787600 followed by a unit qualifier and the quantity

Package 55154-7876-00. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, theref…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55154-7876

What is NDC 55154-7876?
55154-7876 is the product NDC for Baclofen, Baclofen 20 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?
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 077241

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

FDA NDC Directory listings under ANDA 077241
ProductStrengthForm · routeLabelerProduct NDC
BaclofenBaclofen 20 mg/1TabletOralBryant Ranch Prepack72162-1080
BaclofenBaclofen 20 mg/1TabletOralBryant Ranch Prepack71335-0103
BaclofenBaclofen 5 mg/1TabletOralChartwell RX, LLC62135-472
BaclofenBaclofen 10 mg/1TabletOralChartwell RX, LLC62135-473
BaclofenBaclofen 20 mg/1TabletOralChartwell RX, LLC62135-474
BaclofenBaclofen 10 mg/1TabletOralMarlex Pharmaceuticals Inc10135-532
BaclofenBaclofen 20 mg/1TabletOralProficient Rx LP63187-280
BaclofenBaclofen 20 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-444
BaclofenBaclofen 20 mg/1TabletOralMarlex Pharmaceuticals Inc10135-533
BaclofenBaclofen 10 mg/1TabletOralProficient Rx LP63187-313
BaclofenBaclofen 20 mg/1TabletOralMajor Pharmaceuticals0904-6476
BaclofenBaclofen 5 mg/1TabletOralLannett Company, Inc.0527-1333
BaclofenBaclofen 20 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-865
BaclofenBaclofen 20 mg/1TabletOralLannett Company, Inc.0527-1337
BaclofenBaclofen 20 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0112
BaclofenBaclofen 20 mg/1TabletOralBryant Ranch Prepack63629-2084
BaclofenBaclofen 20 mg/1TabletOralBryant Ranch Prepack63629-2083

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