Prescription drug · ANDA
Baclofen NDC 76420-359
Baclofen 20 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-359-00 | 7642003590076420035900 | 1000 TABLET in 1 BOTTLE (76420-359-00)Marketed from May 22, 2025 | |
| 76420-359-01 | 7642003590176420035901 | 100 TABLET in 1 BOTTLE (76420-359-01)Marketed from May 22, 2025 | |
| 76420-359-05 | 7642003590576420035905 | 500 TABLET in 1 BOTTLE (76420-359-05)Marketed from May 22, 2025 | |
| 76420-359-30 | 7642003593076420035930 | 30 TABLET in 1 BOTTLE (76420-359-30)Marketed from May 22, 2025 | |
| 76420-359-60 | 7642003596076420035960 | 60 TABLET in 1 BOTTLE (76420-359-60)Marketed from May 22, 2025 | |
| 76420-359-90 | 7642003599076420035990 | 90 TABLET in 1 BOTTLE (76420-359-90)Marketed from May 22, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209102
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 76420-359_3c3b62bc-64f9-f0cb-e063-6394a90a4a92SPL ID 3c3b62bc-64f9-f0cb-e063-6394a90a4a92SPL set ID 35bccefe-8d2e-85b5-e063-6394a90a58caRxCUI 197391, 197392, 430902, 2679605UNII 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
N476420035900followed by a unit qualifier and the quantityPackage 76420-0359-00. 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, 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.
About NDC 76420-359
- What is NDC 76420-359?
- 76420-359 is the product NDC for Baclofen, Baclofen 20 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 6 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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.
Related NDCs: other Baclofen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Baclofen | Baclofen 10 mg/5mL | SolutionOral | Acella Pharmaceuticals, LLC | 42192-631 | 42192-0631-4042192-0631-45 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4162 | 68788-4162-0168788-4162-0368788-4162-06+2 more |
| Baclofen | Baclofen 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4656 | 70518-4656-00 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Coupler LLC | 67046-1072 | 67046-1072-03 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Medcore LLC | 82461-718 | 82461-0718-10 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Medcore LLC | 82461-717 | 82461-0717-10 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0198 | 55154-0198-00 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0568 | 80425-0568-0180425-0568-0280425-0568-03+1 more |
| Baclofen | Baclofen 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4530 | 70518-4530-0070518-4530-01 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-035 | 84386-0035-01 |
Other NDCs under ANDA 209102
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Baclofen | Baclofen 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7558 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0157 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-480 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-478 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-479 |
| Baclofen | Baclofen 15 mg/1 | TabletOral | Advagen Pharma Limited | 72888-202 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4290 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0949 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4530 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-508 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-357 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-356 |
| Baclofen | Baclofen 15 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-358 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | TruPharma LLC | 52817-321 |
| Baclofen | Baclofen 15 mg/1 | TabletOral | TruPharma LLC | 52817-318 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | TruPharma LLC | 52817-319 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | TruPharma LLC | 52817-320 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | SOLA Pharmaceuticals, LLC | 70512-782 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-312 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0568 |
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