Pregabalin NDC 80425-0433

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0433Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0433Add 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
80425-0433-1	80425043301	30 CAPSULE in 1 BOTTLE (80425-0433-1)Marketed from Aug 22, 2024
80425-0433-2	80425043302	60 CAPSULE in 1 BOTTLE (80425-0433-2)Marketed from Aug 22, 2024
80425-0433-3	80425043303	90 CAPSULE in 1 BOTTLE (80425-0433-3)Marketed from Aug 22, 2024

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 — 25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208677
Marketing start: Aug 22, 2024
Listing expires: Dec 31, 2026
DEA schedule: CV
Identifiers: Product ID 80425-0433_204992ef-3773-0e50-e063-6294a90a8b32SPL ID 204992ef-3773-0e50-e063-6294a90a8b32SPL set ID f98c5df7-9b85-eacc-e053-6294a90a88ecRxCUI 483442, 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

N480425043301 followed by a unit qualifier and the quantity

Package 80425-0433-01. 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.

Other NDCs under ANDA 208677

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

FDA NDC Directory listings under ANDA 208677
Product	Strength	Form · route	Labeler	Product NDC
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-808
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Proficient Rx LP	71205-304
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0177
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Proficient Rx LP	71205-870
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Proficient Rx LP	71205-869
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Proficient Rx LP	71205-874
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Proficient Rx LP	71205-871
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Proficient Rx LP	71205-872
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Proficient Rx LP	71205-873
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Proficient Rx LP	71205-876
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Proficient Rx LP	71205-323
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Proficient Rx LP	71205-875
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-3118
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-799
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-800
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-820
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Proficient Rx LP	71205-396
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Proficient Rx LP	71205-677
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7522
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7520

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