What is NDC 80425-0277?

80425-0277 is the product NDC for Pregabalin, Pregabalin 100 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 80425-0277 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0277Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0277Add 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
80425-0277-1	80425027701	30 CAPSULE in 1 BOTTLE (80425-0277-1)Marketed from May 18, 2023
80425-0277-2	80425027702	60 CAPSULE in 1 BOTTLE (80425-0277-2)Marketed from Mar 30, 2023
80425-0277-3	80425027703	90 CAPSULE in 1 BOTTLE (80425-0277-3)Marketed from Mar 1, 2023

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 — 100 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 208677
Marketing start: Mar 1, 2023
Listing expires: Dec 31, 2026
DEA schedule: CV
Identifiers: Product ID 80425-0277_2a9bf621-afb7-7627-e063-6294a90a77a9SPL ID 2a9bf621-afb7-7627-e063-6294a90a77a9SPL set ID f5d9b625-783c-bd78-e053-2995a90a37d2RxCUI 483438UNII 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

N480425027701 followed by a unit qualifier and the quantity

Package 80425-0277-01. 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 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)

About NDC 80425-0277

What is NDC 80425-0277?: 80425-0277 is the product NDC for Pregabalin, Pregabalin 100 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 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 100 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-442	29300-0442-19
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 300 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-446	29300-0446-19
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

All 510 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 100 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-353
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-350
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-351
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-352
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Proficient Rx LP	71205-677
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	Proficient Rx LP	82804-274
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7522
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Proficient Rx LP	71205-694
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7523
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7524
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Proficient Rx LP	71205-696
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-097
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-618
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7527
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-095
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-096
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Proficient Rx LP	82804-049
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-098

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