NDC codes

FDA NDC Directory
Product NDC (as listed)70710-1666Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70710-1666Add 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
70710-1666-17071016660170710166601100 TABLET in 1 BOTTLE (70710-1666-1)Marketed from Jun 20, 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 — 15 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Zydus Pharmaceuticals (USA) Inc.NDC labeler code 70710
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211659
Marketing start
Listing expires
Other FDA classes
GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers
Product ID 70710-1666_f96d29a2-071a-4a33-a57e-bb55eba0d660SPL ID f96d29a2-071a-4a33-a57e-bb55eba0d660SPL set ID cfc49176-8d01-4c39-9319-604dd087065cRxCUI 197391, 197392, 430902, 2679605UNII H789N3FKE8UPC 0370710128517, 0370710128616, 0370710160913
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

N470710166601 followed by a unit qualifier and the quantity

Package 70710-1666-01. 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 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 70710-1666

What is NDC 70710-1666?
70710-1666 is the product NDC for Baclofen, Baclofen 15 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. 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?
Zydus Pharmaceuticals (USA) Inc., NDC labeler code 70710. 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 211659

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

FDA NDC Directory listings under ANDA 211659
ProductStrengthForm · routeLabelerProduct NDC
BaclofenBaclofen 10 mg/1TabletOralAmerican Health Packaging60687-815
BaclofenBaclofen 15 mg/1TabletOralZydus Lifesciences Limited70771-1868
BaclofenBaclofen 20 mg/1TabletOralAmerican Health Packaging60687-826
BaclofenBaclofen 20 mg/1TabletOralA-S Medication Solutions50090-4682
BaclofenBaclofen 5 mg/1TabletOralZydus Lifesciences Limited70771-1586
BaclofenBaclofen 20 mg/1TabletOralBryant Ranch Prepack71335-1356
BaclofenBaclofen 10 mg/1TabletOralA-S Medication Solutions50090-6149
BaclofenBaclofen 5 mg/1TabletOralCardinal Health 107, LLC55154-4349
BaclofenBaclofen 10 mg/1TabletOralAvPAK50268-106
BaclofenBaclofen 5 mg/1TabletOralAvPAK50268-105
BaclofenBaclofen 20 mg/1TabletOralAvPAK50268-107
BaclofenBaclofen 10 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.70710-1285
BaclofenBaclofen 20 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.70710-1286
BaclofenBaclofen 10 mg/1TabletOralCoupler LLC67046-1072
BaclofenBaclofen 5 mg/1TabletOralAmerican Health Packaging60687-804
BaclofenBaclofen 10 mg/1TabletOralZydus Lifesciences Limited70771-1448
BaclofenBaclofen 20 mg/1TabletOralZydus Lifesciences Limited70771-1449
BaclofenBaclofen 10 mg/1TabletOralA-S Medication Solutions50090-7928
BaclofenBaclofen 5 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.70710-1609

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