Prescription drug · ANDA
Baclofen NDC 71335-1356
Baclofen 20 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1356-0 | 71335135600 | 120 TABLET in 1 BOTTLE (71335-1356-0)Marketed from Mar 17, 2020 | |
| 71335-1356-1 | 71335135601 | 90 TABLET in 1 BOTTLE (71335-1356-1)Marketed from Nov 13, 2019 | |
| 71335-1356-2 | 71335135602 | 20 TABLET in 1 BOTTLE (71335-1356-2)Marketed from Sep 5, 2024 | |
| 71335-1356-3 | 71335135603 | 60 TABLET in 1 BOTTLE (71335-1356-3)Marketed from Dec 6, 2019 | |
| 71335-1356-4 | 71335135604 | 45 TABLET in 1 BOTTLE (71335-1356-4)Marketed from Sep 5, 2024 | |
| 71335-1356-5 | 71335135605 | 112 TABLET in 1 BOTTLE (71335-1356-5)Marketed from Sep 5, 2024 | |
| 71335-1356-6 | 71335135606 | 30 TABLET in 1 BOTTLE (71335-1356-6)Marketed from Apr 20, 2020 | |
| 71335-1356-7 | 71335135607 | 56 TABLET in 1 BOTTLE (71335-1356-7)Marketed from Sep 5, 2024 | |
| 71335-1356-8 | 71335135608 | 15 TABLET in 1 BOTTLE (71335-1356-8)Marketed from Sep 5, 2024 | |
| 71335-1356-9 | 71335135609 | 84 TABLET in 1 BOTTLE (71335-1356-9)Marketed from Sep 5, 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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-1356_018c5e52-baa0-4aff-a1ff-604cc1bf20a9SPL ID 018c5e52-baa0-4aff-a1ff-604cc1bf20a9SPL set ID 5b92b0a6-ebba-4815-8b94-f2014674399bRxCUI 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
N471335135600followed by a unit qualifier and the quantityPackage 71335-1356-00. 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, theref…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211659
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 | Zydus Lifesciences Limited | 70771-1586 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7928 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-4682 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1286 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4349 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1285 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | AvPAK | 50268-105 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | AvPAK | 50268-106 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | AvPAK | 50268-107 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6149 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1448 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1449 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Coupler LLC | 67046-1072 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1609 |
| Baclofen | Baclofen 15 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1868 |
| Baclofen | Baclofen 15 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1666 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | American Health Packaging | 60687-804 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | American Health Packaging | 60687-815 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | American Health Packaging | 60687-826 |