NDC codes

FDA NDC Directory
Product NDC (as listed)0832-1054Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00832-1054Add 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
0832-1054-1000832105410008321054101000 TABLET in 1 BOTTLE (0832-1054-10)Marketed from Feb 27, 2018
0832-1054-110083210541100832105411100 TABLET in 1 BOTTLE (0832-1054-11)Marketed from Feb 27, 2018
0832-1054-150083210541500832105415500 TABLET in 1 BOTTLE (0832-1054-15)Marketed from Feb 27, 2018
0832-1054-90008321054900083210549090 TABLET in 1 BOTTLE (0832-1054-90)Marketed from Feb 27, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Upsher-Smith Laboratories, LLCNDC labeler code 0832
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074584
Marketing start
Marketing end
Other FDA classes
GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers
Product ID 0832-1054_45af8926-ad18-a93a-e063-6294a90a1dcaSPL ID 45af8926-ad18-a93a-e063-6294a90a1dcaSPL set ID b2747a9d-5fca-4657-9e4b-4112607f30d8RxCUI 197391, 197392UNII 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 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

N400832105410 followed by a unit qualifier and the quantity

Package 00832-1054-10. 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 .

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, the…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0832-1054

What is NDC 0832-1054?
0832-1054 is the product NDC for Baclofen, Baclofen 10 mg/1 tablet, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 4 package NDCs, 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?
Upsher-Smith Laboratories, LLC, NDC labeler code 0832. 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 074584

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

FDA NDC Directory listings under ANDA 074584
ProductStrengthForm · routeLabelerProduct NDC
BaclofenBaclofen 10 mg/1TabletOralA-S Medication Solutions50090-6868
BaclofenBaclofen 10 mg/1TabletOralA-S Medication Solutions50090-6869

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