Prescription drug · ANDA
Pregabalin NDC 67046-1494
Pregabalin 50 mg/1 · Capsule · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1494-3 | 6704614940367046149403 | 30 CAPSULE in 1 BLISTER PACK (67046-1494-3)Marketed from Jan 28, 2025 |
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)
- Pregabalin
- Generic name (nonproprietary)
- pregabalin
- Active ingredients
- Pregabalin — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205321
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 67046-1494_2ccc687b-f886-2ce4-e063-6394a90ac359SPL ID 2ccc687b-f886-2ce4-e063-6394a90ac359SPL set ID 2ccc641e-6859-046e-e063-6294a90a5017RxCUI 483448UNII 55JG375S6M
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
N467046149403followed by a unit qualifier and the quantityPackage 67046-1494-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 67046-1494
- What is NDC 67046-1494?
- 67046-1494 is the product NDC for Pregabalin, Pregabalin 50 mg/1 capsule, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pregabalin.
- What is the active ingredient?
- Pregabalin.
- Who is the labeler?
- Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pregabalin?
- 509 other product NDCs are listed under this name. See all Pregabalin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pregabalin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4778 | 70518-4778-00 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4749 | 70518-4749-00 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4743 | 70518-4743-00 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4715 | 70518-4715-00 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4716 | 70518-4716-00 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-439 | 29300-0439-19 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-440 | 29300-0440-19 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-444 | 29300-0444-19 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-441 | 29300-0441-19 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-442 | 29300-0442-19 |
Other NDCs under ANDA 205321
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 |
|---|---|---|---|---|
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1680 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-760 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-758 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-759 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-763 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-761 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-762 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-764 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-765 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0758 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0759 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0763 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0760 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0761 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0762 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0764 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0765 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1628 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-871 |