NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8726Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8726Add 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
68788-8726-16878887260168788872601100 TABLET in 1 BOTTLE (68788-8726-1)Marketed from Aug 16, 2024
68788-8726-3687888726036878887260330 TABLET in 1 BOTTLE (68788-8726-3)Marketed from Aug 16, 2024
68788-8726-6687888726066878887260660 TABLET in 1 BOTTLE (68788-8726-6)Marketed from Aug 16, 2024
68788-8726-86878887260868788872608120 TABLET in 1 BOTTLE (68788-8726-8)Marketed from Aug 16, 2024
68788-8726-9687888726096878887260990 TABLET in 1 BOTTLE (68788-8726-9)Marketed from Aug 16, 2024

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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214374
Marketing start
Listing expires
Other FDA classes
GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers
Product ID 68788-8726_14664cc5-700a-44e4-bd73-b8f4cbd8c1e8SPL ID 14664cc5-700a-44e4-bd73-b8f4cbd8c1e8SPL set ID 5e479876-adfb-4590-ac10-3924ff7988b0RxCUI 197391UNII 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

N468788872601 followed by a unit qualifier and the quantity

Package 68788-8726-01. 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 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 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, therefore, it…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8726

What is NDC 68788-8726?
68788-8726 is the product NDC for Baclofen, Baclofen 10 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 214374

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

FDA NDC Directory listings under ANDA 214374
ProductStrengthForm · routeLabelerProduct NDC
BaclofenBaclofen 5 mg/1TabletOralRising Pharma Holdings, Inc.16571-169
BaclofenBaclofen 10 mg/1TabletOralRising Pharma Holdings, Inc.16571-171
BaclofenBaclofen 20 mg/1TabletOralRising Pharma Holdings, Inc.16571-172
BaclofenBaclofen 10 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3700
BaclofenBaclofen 10 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-5327
BaclofenBaclofen 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8737
BaclofenBaclofen 20 mg/1TabletOralREMEDYREPACK INC.70518-4235
BaclofenBaclofen 10 mg/1TabletOralREMEDYREPACK INC.70518-4384
BaclofenBaclofen 20 mg/1TabletOralBryant Ranch Prepack71335-2497
BaclofenBaclofen 5 mg/1TabletOralBryant Ranch Prepack71335-3050
BaclofenBaclofen 10 mg/1TabletOralBryant Ranch Prepack71335-9759
BaclofenBaclofen 20 mg/1TabletOralDirect_rx72189-565
BaclofenBaclofen 20 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0478

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