What is NDC 53401-007?

53401-007 is the product NDC for Pregabalin, Pregabalin 50 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. 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 53401-007 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53401-007Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53401-0007Add 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
53401-007-30	5340100073053401000730	30 CAPSULE in 1 BOTTLE (53401-007-30)Marketed from Apr 7, 2026
53401-007-46	5340100074653401000746	56 CAPSULE in 1 BOTTLE (53401-007-46)Marketed from Apr 15, 2026
53401-007-53	5340100075353401000753	60 CAPSULE in 1 BOTTLE (53401-007-53)Marketed from Apr 7, 2026
53401-007-70	5340100077053401000770	120 CAPSULE in 1 BOTTLE (53401-007-70)Marketed from Apr 21, 2026
53401-007-75	5340100077553401000775	150 CAPSULE in 1 BOTTLE (53401-007-75)Marketed from Apr 21, 2026
53401-007-80	5340100078053401000780	180 CAPSULE in 1 BOTTLE (53401-007-80)Marketed from Apr 21, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208677
Marketing start: Dec 10, 2025
Listing expires: Dec 31, 2027
DEA schedule: CV
Identifiers: Product ID 53401-007_4ffdeea2-0b32-7965-e063-6394a90a59d9SPL ID 4ffdeea2-0b32-7965-e063-6394a90a59d9SPL set ID 4ef59b1c-1273-5e54-e063-6294a90a0ec9RxCUI 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

N453401000730 followed by a unit qualifier and the quantity

Package 53401-0007-30. 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 Apr 21, 2026.

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 53401-007

What is NDC 53401-007?: 53401-007 is the product NDC for Pregabalin, Pregabalin 50 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 6 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. 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 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 75 mg/1	CapsuleOral	A-S Medication Solutions	50090-5038
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 100 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-353
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-354
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-355
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-356
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-357
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-645
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-646
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-647
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-648
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-649
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-650
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-651
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-652
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Golden State Medical Supply, Inc.	51407-574
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Golden State Medical Supply, Inc.	51407-575
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Golden State Medical Supply, Inc.	51407-576

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