Prescription drug · ANDA
Baclofen NDC 0527-1333
Baclofen 5 mg/1 · Tablet · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-1333-01 | 00527133301 | 100 TABLET in 1 BOTTLE, PLASTIC (0527-1333-01)Marketed from Sep 22, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077241
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 0527-1333_153f6bd7-9462-4d92-b738-48e7807c5919SPL ID 153f6bd7-9462-4d92-b738-48e7807c5919SPL set ID f84f3f4c-17e6-43f1-9600-63b0b175837bRxCUI 197391, 197392, 430902UNII H789N3FKE8UPC 0305271333018
- 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
N400527133301followed by a unit qualifier and the quantityPackage 00527-1333-01. 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 077241
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 20 mg/1 | TabletOral | Proficient Rx LP | 63187-280 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-865 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Marlex Pharmaceuticals Inc | 10135-532 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Marlex Pharmaceuticals Inc | 10135-533 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Proficient Rx LP | 63187-313 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6476 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1080 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0103 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Lannett Company, Inc. | 0527-1337 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0112 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-444 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2083 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2084 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7876 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Chartwell RX, LLC | 62135-474 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-472 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Chartwell RX, LLC | 62135-473 |