Prescription drug · ANDA
Pregabalin NDC 72189-019
Pregabalin 50 mg/1 · Capsule · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-019-82 | 72189001982 | 180 CAPSULE in 1 BOTTLE (72189-019-82)Marketed from Jul 31, 2019 | |
| 72189-019-90 | 72189001990 | 90 CAPSULE in 1 BOTTLE (72189-019-90)Marketed from Jul 31, 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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208677
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 72189-019_2c4e85d7-3b08-6b90-e063-6294a90a0ea8SPL ID 2c4e85d7-3b08-6b90-e063-6294a90a0ea8SPL set ID 8efb9652-86b9-4cb5-e053-2995a90adac0RxCUI 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
N472189001982followed by a unit qualifier and the quantityPackage 72189-0019-82. 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 17 years of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Excerpt only. Read the full label for complete information.
About NDC 72189-019
- What is NDC 72189-019?
- 72189-019 is the product NDC for Pregabalin, Pregabalin 50 mg/1 capsule, listed with the FDA by Direct_Rx. It has 2 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?
- Direct_Rx, NDC labeler code 72189. 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?
- 507 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 208677
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 75 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5038 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-350 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-351 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-352 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-353 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-354 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-355 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-356 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-357 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-645 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-646 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-647 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-648 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-649 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-650 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-651 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-652 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-574 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-575 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-576 |
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