Pregabalin Extended Release (pregabalin) NDC 50228-462

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-462Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0462Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50228-462-05	50228046205	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-05)Marketed from Sep 14, 2022
50228-462-30	50228046230	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-30)Marketed from Sep 14, 2022

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 Extended Release
Generic name (nonproprietary): pregabalin
Active ingredients: Pregabalin — 82.5 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: ScieGen Pharmaceuticals, INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215675
Marketing start: Sep 14, 2022
Listing expires: Dec 31, 2026
DEA schedule: CV
Identifiers: Product ID 50228-462_e90bfe09-9adb-03c0-e053-2a95a90a061eSPL ID e90bfe09-9adb-03c0-e053-2a95a90a061eSPL set ID 1544a657-353c-47f8-96ac-a63fa78373f0RxCUI 1988974, 1988977, 1988980UNII 55JG375S6MUPC 0350228463300, 0350228464055, 0350228464307, 0350228462303, 0350228463058, 0350228462051

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

N450228046205 followed by a unit qualifier and the quantity

Package 50228-0462-05. 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 Sep 19, 2022.

Indications (excerpt from the label)

Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy Postherpetic neuralgia Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) Postherpetic neuralgia (PHN) ( 1 ) Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seiz…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215675

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 215675
Product	Strength	Form · route	Labeler	Product NDC
Pregabalin Extended Releasepregabalin	Pregabalin 165 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, INC.	50228-463
Pregabalin Extended Releasepregabalin	Pregabalin 330 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, INC.	50228-464