What is NDC 80425-0399?

80425-0399 is the product NDC for Pregabalin, Pregabalin 225 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?

503 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pregabalin NDC 80425-0399 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0399Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0399Add 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
80425-0399-1	8042503990180425039901	30 CAPSULE in 1 BOTTLE (80425-0399-1)Marketed from Jun 4, 2024
80425-0399-2	8042503990280425039902	60 CAPSULE in 1 BOTTLE (80425-0399-2)Marketed from Jun 4, 2024
80425-0399-3	8042503990380425039903	90 CAPSULE in 1 BOTTLE (80425-0399-3)Marketed from Jun 4, 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 — 225 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208677
Marketing start: Jun 4, 2024
Listing expires: Dec 31, 2026
DEA schedule: CV
Identifiers: Product ID 80425-0399_1a280b06-dc3b-3735-e063-6394a90ab02bSPL ID 1a280b06-dc3b-3735-e063-6394a90ab02bSPL set ID 1a15cd11-0db9-2bc8-e063-6394a90a11fbRxCUI 483440, 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

N480425039901 followed by a unit qualifier and the quantity

Package 80425-0399-01. 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 Jun 5, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0399

What is NDC 80425-0399?: 80425-0399 is the product NDC for Pregabalin, Pregabalin 225 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 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?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?: 503 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pregabalin NDCs
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

All 504 Pregabalin NDCs

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 50 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-351
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-350
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-3118
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7522
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7520
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7521
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0277
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7523
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7524
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-800
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7527
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	A-S Medication Solutions	50090-5038
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-799
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-355
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-356
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0028
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-357
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Proficient Rx LP	71205-396
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7656
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-820

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