Prescription drug · ANDA
pregabalin NDC 43598-291
Pregabalin 25 mg/1 · Capsule · Oral · Dr.Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-291-05 | 4359802910543598029105 | 500 CAPSULE in 1 BOTTLE (43598-291-05)Marketed from Jul 19, 2019 | |
| 43598-291-66 | 4359802916643598029166 | 5 BLISTER PACK in 1 CARTON (43598-291-66) / 10 CAPSULE in 1 BLISTER PACK (43598-291-79)Marketed from Jul 19, 2019 | |
| 43598-291-78 | 4359802917843598029178 | 10 BLISTER PACK in 1 CARTON (43598-291-78) / 10 CAPSULE in 1 BLISTER PACK (43598-291-79)Marketed from Jul 19, 2019 | |
| 43598-291-90 | 4359802919043598029190 | 90 CAPSULE in 1 BOTTLE (43598-291-90)Marketed from Jul 19, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- pregabalin
- Generic name (nonproprietary)
- pregabalin
- Active ingredients
- Pregabalin — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Dr.Reddys Laboratories IncNDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209664
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 43598-291_4a1e5038-d049-606f-c087-48bc353a8a69SPL ID 4a1e5038-d049-606f-c087-48bc353a8a69SPL set ID ceed457b-8f43-4021-fd70-071c96e09470RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 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
N443598029105followed by a unit qualifier and the quantityPackage 43598-0291-05. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Pregabalin capsules are indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropath y • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 Month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) • Postherpetic neuralgia (PHN) (1) • Adjunctive therapy for for the treatment of partial-onset seizures in patients 1 month of age and older (1) • Fibromyalgia (1) • Neuropathic pain associated with spinal cord injury (1)…
Excerpt only. Read the full label for complete information.
About NDC 43598-291
- What is NDC 43598-291?
- 43598-291 is the product NDC for pregabalin, Pregabalin 25 mg/1 capsule, listed with the FDA by Dr.Reddys Laboratories Inc. It has 4 package NDCs, 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?
- Dr.Reddys Laboratories Inc, NDC labeler code 43598. 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?
- 503 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 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 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 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 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-443 | 29300-0443-19 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-444 | 29300-0444-19 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-445 | 29300-0445-19 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-446 | 29300-0446-19 |
Other NDCs under ANDA 209664
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 50 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-292 |
| pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-293 |
| pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-294 |
| pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-295 |
| pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-296 |
| pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-297 |
| pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-298 |