Prescription drug · ANDA
Baclofen NDC 68071-5327
Baclofen 10 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-5327-3 | 6807153270368071532703 | 3 TABLET in 1 BOTTLE (68071-5327-3)Marketed from Oct 6, 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214374
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 68071-5327_5d2e2247-9e0b-e178-e063-6394a90a35c2SPL ID 5d2e2247-9e0b-e178-e063-6394a90a35c2
- 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
N468071532703followed by a unit qualifier and the quantityPackage 68071-5327-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68071-5327
- What is NDC 68071-5327?
- 68071-5327 is the product NDC for Baclofen, Baclofen 10 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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?
- 217 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 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 10 mg/1 | TabletOral | Medcore LLC | 82461-717 | 82461-0717-10 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Medcore LLC | 82461-718 | 82461-0718-10 |
| 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 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7552 | 00904-7552-61 |
Other NDCs under ANDA 214374
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 | Rising Pharma Holdings, Inc. | 16571-169 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-171 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-172 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3700 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8726 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8737 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4235 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4384 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2497 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3050 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9759 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Direct_rx | 72189-565 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0478 |