Prescription drug · ANDA
PREGABALIN capsules, CV NDC 69097-679
Pregabalin 75 mg/1 · Capsule · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-679-05 | 69097067905 | 90 CAPSULE in 1 BOTTLE (69097-679-05)Marketed from Jan 10, 2020 |
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 capsules, CV
- Generic name (nonproprietary)
- pregabalin capsules, cv
- Active ingredients
- Pregabalin — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212280
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 69097-679_22a469ee-1346-4abb-84f1-4c2caf26437bSPL ID 22a469ee-1346-4abb-84f1-4c2caf26437bSPL set ID 7d93359c-1849-430d-a922-21d42932d0f3RxCUI 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
N469097067905followed by a unit qualifier and the quantityPackage 69097-0679-05. 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 neuropathy 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 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.
Other NDCs under ANDA 212280
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 capsules, CV | Pregabalin 100 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-681 |
| PREGABALIN capsules, CV | Pregabalin 25 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-677 |
| PREGABALIN capsules, CV | Pregabalin 50 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-678 |
| PREGABALIN capsules, CV | Pregabalin 300 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-685 |
| PREGABALIN capsules, CV | Pregabalin 150 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-682 |
| PREGABALIN capsules, CV | Pregabalin 200 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-683 |
| PREGABALIN capsules, CV | Pregabalin 225 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-684 |