What is NDC 71610-618?

71610-618 is the product NDC for Pregabalin, Pregabalin 150 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-618 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-618Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0618Add 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
71610-618-30	7161006183071610061830	30 CAPSULE in 1 BOTTLE (71610-618-30)Marketed from May 31, 2022
71610-618-46	7161006184671610061846	56 CAPSULE in 1 BOTTLE (71610-618-46)Marketed from May 31, 2022
71610-618-53	7161006185371610061853	60 CAPSULE in 1 BOTTLE (71610-618-53)Marketed from Dec 2, 2021
71610-618-54	7161006185471610061854	84 CAPSULE in 1 BOTTLE (71610-618-54)Marketed from Jul 16, 2024
71610-618-70	7161006187071610061870	120 CAPSULE in 1 BOTTLE (71610-618-70)Marketed from May 31, 2022

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 — 150 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208677
Marketing start: Jul 19, 2019
Listing expires: Dec 31, 2026
DEA schedule: CV
Identifiers: Product ID 71610-618_d2de5bd4-13ac-4b83-8fa2-a75513e408fcSPL ID d2de5bd4-13ac-4b83-8fa2-a75513e408fcSPL set ID aa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ecRxCUI 483440, 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

N471610061830 followed by a unit qualifier and the quantity

Package 71610-0618-30. 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 Jul 28, 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 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. Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-618

What is NDC 71610-618?: 71610-618 is the product NDC for Pregabalin, Pregabalin 150 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 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 71610. 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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