Prescription drug · ANDA
Baclofen NDC 70518-3115
Baclofen 20 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3115-1 | 70518311501 | 30 TABLET in 1 BLISTER PACK (70518-3115-1)Marketed from Jul 1, 2021 |
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 212378
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 70518-3115_56923e09-ce03-0ba3-e063-6294a90ab11fSPL ID 56923e09-ce03-0ba3-e063-6294a90ab11fSPL set ID 6274e70a-fb57-461b-b1bc-39d4ff916b2aRxCUI 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
N470518311501followed by a unit qualifier and the quantityPackage 70518-3115-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 212378
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 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1797 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1796 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0205 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3089 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2668 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2669 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-730 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-731 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-732 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1225 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0282 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-930 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-931 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-932 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1224 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1227 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1228 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2482 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-660 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2767 |
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