Prescription drug · ANDA
Baclofen NDC 70518-4378
Baclofen 20 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4378-0 | 70518437800 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4378-0)Marketed from Jul 1, 2025 | |
| 70518-4378-1 | 70518437801 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-4378-1)Marketed from Jun 30, 2026 |
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
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215885
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 70518-4378_557b225e-4cb8-7415-e063-6394a90aa056SPL ID 557b225e-4cb8-7415-e063-6394a90aa056SPL set ID ebbfec9e-621c-4d04-8a1c-81d2eb9e9c74RxCUI 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
N470518437800followed by a unit qualifier and the quantityPackage 70518-4378-00. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 215885
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 | Golden State Medical Supply, Inc. | 51407-972 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-973 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-974 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-085 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-288 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-289 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0198 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8518 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-921 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-924 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7552 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7553 |