What is NDC 80425-0421?

80425-0421 is the product NDC for Pregabalin, Pregabalin 50 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy 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?

509 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 80425-0421 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0421Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0421Add 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
80425-0421-1	8042504210180425042101	30 CAPSULE in 1 BOTTLE (80425-0421-1)Marketed from Jul 15, 2024
80425-0421-2	8042504210280425042102	60 CAPSULE in 1 BOTTLE (80425-0421-2)Marketed from Jul 15, 2024
80425-0421-3	8042504210380425042103	90 CAPSULE in 1 BOTTLE (80425-0421-3)Marketed from Jul 15, 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 — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207799
Marketing start: Jul 15, 2024
Listing expires: Dec 31, 2026
DEA schedule: CV
Identifiers: Product ID 80425-0421_27606bf8-5738-d374-e063-6394a90a10f9SPL ID 27606bf8-5738-d374-e063-6394a90a10f9SPL set ID d2813712-d7f6-6144-e053-2995a90a3c5dRxCUI 483440, 483448, 483450UNII 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

N480425042101 followed by a unit qualifier and the quantity

Package 80425-0421-01. 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 Nov 20, 2024.

Indications (excerpt from the label)

1. Indications and Usage Pregabalin is 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)

About NDC 80425-0421

What is NDC 80425-0421?: 80425-0421 is the product NDC for Pregabalin, Pregabalin 50 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy 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 Pharmacy 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?: 509 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 225 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4778	70518-4778-00
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 75 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4715	70518-4715-00
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4716	70518-4716-00
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 200 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-444	29300-0444-19
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

All 510 Pregabalin NDCs

Other NDCs under ANDA 207799

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

FDA NDC Directory listings under ANDA 207799
Product	Strength	Form · route	Labeler	Product NDC
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0185
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0160
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0417
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1740
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4481
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1745
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-729
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1751
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1758
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1762
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Proficient Rx LP	71205-608
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-462
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-466
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-463
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Proficient Rx LP	71205-621
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-464
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-465
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-467
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-468
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-469

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