NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2219Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2219Add 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
71335-2219-07133522190071335221900120 TABLET in 1 BOTTLE (71335-2219-0)Marketed from Aug 15, 2023
71335-2219-1713352219017133522190190 TABLET in 1 BOTTLE (71335-2219-1)Marketed from Aug 15, 2023
71335-2219-2713352219027133522190220 TABLET in 1 BOTTLE (71335-2219-2)Marketed from Aug 15, 2023
71335-2219-3713352219037133522190360 TABLET in 1 BOTTLE (71335-2219-3)Marketed from Aug 15, 2023
71335-2219-4713352219047133522190445 TABLET in 1 BOTTLE (71335-2219-4)Marketed from Aug 15, 2023
71335-2219-57133522190571335221905112 TABLET in 1 BOTTLE (71335-2219-5)Marketed from Aug 15, 2023
71335-2219-6713352219067133522190630 TABLET in 1 BOTTLE (71335-2219-6)Marketed from Aug 15, 2023
71335-2219-7713352219077133522190756 TABLET in 1 BOTTLE (71335-2219-7)Marketed from Aug 15, 2023
71335-2219-8713352219087133522190815 TABLET in 1 BOTTLE (71335-2219-8)Marketed from Aug 15, 2023
71335-2219-9713352219097133522190984 TABLET in 1 BOTTLE (71335-2219-9)Marketed from Aug 15, 2023

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
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214099
Marketing start
Listing expires
Other FDA classes
GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers
Product ID 71335-2219_a61f8df2-6383-497b-93b0-70b1da356068SPL ID a61f8df2-6383-497b-93b0-70b1da356068SPL set ID 844a09ab-6c11-44fa-a09b-09e2b7a3759eRxCUI 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

N471335221900 followed by a unit qualifier and the quantity

Package 71335-2219-00. 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 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 in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2219

What is NDC 71335-2219?
71335-2219 is the product NDC for Baclofen, Baclofen 20 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 214099

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

FDA NDC Directory listings under ANDA 214099
ProductStrengthForm · routeLabelerProduct NDC
BaclofenBaclofen 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3407
BaclofenBaclofen 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8575
BaclofenBaclofen 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8584
BaclofenBaclofen 20 mg/1TabletOralREMEDYREPACK INC.70518-3467
BaclofenBaclofen 10 mg/1TabletOralAsclemed USA, Inc.76420-241
BaclofenBaclofen 20 mg/1TabletOralAsclemed USA, Inc.76420-242
BaclofenBaclofen 20 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0466
BaclofenBaclofen 20 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0467
BaclofenBaclofen 10 mg/1TabletOralMedcore LLC82461-717
BaclofenBaclofen 20 mg/1TabletOralMedcore LLC82461-718
BaclofenBaclofen 20 mg/1TabletOralQuality Care Products, LLC83008-062
BaclofenBaclofen 5 mg/1TabletOralAurobindo Pharma Limited84386-035
BaclofenBaclofen 20 mg/1TabletOralHAWAII REPACK, INC.85534-0004

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in