NDC codes

FDA NDC Directory
Product NDC (as listed)85509-1344Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85509-1344Add 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
85509-1344-3855091344038550913440330 TABLET in 1 BOTTLE (85509-1344-3)Marketed from Dec 12, 2025
85509-1344-6855091344068550913440660 TABLET in 1 BOTTLE (85509-1344-6)Marketed from Dec 12, 2025
85509-1344-9855091344098550913440990 TABLET in 1 BOTTLE (85509-1344-9)Marketed from Dec 12, 2025

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
PHOENIX RX LLCNDC labeler code 85509
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212067
Marketing start
Listing expires
Other FDA classes
GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers
Product ID 85509-1344_45c6d07c-9d2b-91c2-e063-6394a90aecfdSPL ID 45c6d07c-9d2b-91c2-e063-6394a90aecfdSPL set ID 45c6d45d-95d5-21b8-e063-6294a90a7955RxCUI 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

N485509134403 followed by a unit qualifier and the quantity

Package 85509-1344-03. 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 tablets treatment will aid in restoring residual function. Baclofen tablets 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 tablets in stroke, cerebral palsy, and Parkinson's disease has not been established and, th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85509-1344

What is NDC 85509-1344?
85509-1344 is the product NDC for Baclofen, Baclofen 20 mg/1 tablet, listed with the FDA by PHOENIX RX LLC. It has 3 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?
PHOENIX RX LLC, NDC labeler code 85509. 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 212067

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

FDA NDC Directory listings under ANDA 212067
ProductStrengthForm · routeLabelerProduct NDC
BaclofenBaclofen 10 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-343
BaclofenBaclofen 20 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-344
BaclofenBaclofen 5 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-474
BaclofenBaclofen 10 mg/1TabletOralRedpharm Drug67296-1947
BaclofenBaclofen 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4162
BaclofenBaclofen 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8783
BaclofenBaclofen 10 mg/1TabletOralREMEDYREPACK INC.70518-4249
BaclofenBaclofen 10 mg/1TabletOralBryant Ranch Prepack71335-2392
BaclofenBaclofen 20 mg/1TabletOralBryant Ranch Prepack71335-2756
BaclofenBaclofen 5 mg/1TabletOralBryant Ranch Prepack72162-2448
BaclofenBaclofen 10 mg/1TabletOralBryant Ranch Prepack72162-2449
BaclofenBaclofen 20 mg/1TabletOralBryant Ranch Prepack72162-2450
BaclofenBaclofen 10 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0391
BaclofenBaclofen 20 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0459

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