Pregabalin NDC 80425-0027

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0027Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0027Add 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
80425-0027-1	80425002701	60 CAPSULE in 1 BOTTLE (80425-0027-1)Marketed from Jul 19, 2019

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 — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Advanced Rx of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210432
Marketing start: Jul 19, 2019
Listing expires: Dec 31, 2026
DEA schedule: CV
Identifiers: Product ID 80425-0027_2a987953-08cf-1c4c-e063-6394a90a5a82SPL ID 2a987953-08cf-1c4c-e063-6394a90a5a82SPL set ID afc8d9f1-df31-607b-e053-2995a90a028cRxCUI 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

N480425002701 followed by a unit qualifier and the quantity

Package 80425-0027-01. 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

Current FDA label (SPL), effective Dec 31, 2024.

Indications (excerpt from the label)

1. Indications and Usage Section 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210432

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

FDA NDC Directory listings under ANDA 210432
Product	Strength	Form · route	Labeler	Product NDC
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	American Health Packaging	60687-484
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	American Health Packaging	60687-495
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	American Health Packaging	60687-506
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	American Health Packaging	60687-517
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-8097
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-8098
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Proficient Rx LP	71205-338
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1459
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1476
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1475
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-4308
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	A-S Medication Solutions	50090-6793
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1505
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Major Pharmaceuticals	0904-6991
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1555
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4569
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2304
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Major Pharmaceuticals	0904-6992
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7000
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7001

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