What is NDC 70518-3597?

70518-3597 is the product NDC for Pregabalin, Pregabalin 75 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.

REMEDYREPACK INC., NDC labeler code 70518. 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 70518-3597 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-3597Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-3597Add 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
70518-3597-0	70518359700	90 CAPSULE in 1 BOTTLE, PLASTIC (70518-3597-0)Marketed from Dec 21, 2022
70518-3597-1	70518359701	60 CAPSULE in 1 BOTTLE, PLASTIC (70518-3597-1)Marketed from Feb 16, 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 — 75 mg/1
Dosage form: Capsule
Route: Oral
Labeler: REMEDYREPACK INC.NDC labeler code 70518
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207799
Marketing start: Dec 21, 2022
Listing expires: Dec 31, 2027
DEA schedule: CV
Identifiers: Product ID 70518-3597_590262f8-1594-fcb9-e063-6294a90a5edfSPL ID 590262f8-1594-fcb9-e063-6294a90a5edfSPL set ID 12309847-0857-4ff7-a7e7-edeadc3dfb61RxCUI 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

N470518359700 followed by a unit qualifier and the quantity

Package 70518-3597-00. 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 Aug 14, 2026.

Indications (excerpt from the label)

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 1 month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pregabalin is 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 70518-3597

What is NDC 70518-3597?: 70518-3597 is the product NDC for Pregabalin, Pregabalin 75 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. It has 2 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?: REMEDYREPACK INC., NDC labeler code 70518. 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 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 25 mg/1	CapsuleOral	Clinical Solutions Wholesale, LLC	58118-1462
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Clinical Solutions Wholesale, LLC	58118-1466
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Clinical Solutions Wholesale, LLC	58118-1463
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Clinical Solutions Wholesale, LLC	58118-1464
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Clinical Solutions Wholesale, LLC	58118-1465
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Clinical Solutions Wholesale, LLC	58118-1467
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0417
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0160
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0421
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8360
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0185
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8391
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3643
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3636
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3647
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3646
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1740
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1745
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1751
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1758

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