What is NDC 71610-631?

71610-631 is the product NDC for Gabapentin, Gabapentin 400 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 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 Gabapentin?

558 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gabapentin NDC 71610-631 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-631Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0631Add 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
71610-631-53	71610063153	60 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-53)Marketed from Jan 31, 2022
71610-631-60	71610063160	90 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-60)Marketed from Jan 31, 2022
71610-631-80	71610063180	180 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-80)Marketed from Jan 31, 2022
71610-631-92	71610063192	270 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-92)Marketed from Jan 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): Gabapentin
Generic name (nonproprietary): gabapentin
Active ingredients: Gabapentin — 400 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 204989
Marketing start: Feb 18, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 71610-631_2b5aee3a-519c-0872-e063-6294a90a1bb9SPL ID 2b5aee3a-519c-0872-e063-6294a90a1bb9SPL set ID 95757436-2093-41cf-a9a9-ef2f28ac096fRxCUI 310432UNII 6CW7F3G59X

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

N471610063153 followed by a unit qualifier and the quantity

Package 71610-0631-53. 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 Jan 9, 2025.

Indications (excerpt from the label)

Gabapentin is indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin is indicated for: Postherpetic neuralgia in adults ( 1 ) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-631

What is NDC 71610-631?: 71610-631 is the product NDC for Gabapentin, Gabapentin 400 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gabapentin.
What is the active ingredient?: Gabapentin.
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 Gabapentin?: 558 other product NDCs are listed under this name. See all Gabapentin 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 Gabapentin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
gabapentin	Gabapentin 300 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4763	70518-4763-00
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0581	55154-0581-00
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0595	80425-0595-0180425-0595-0280425-0595-03+1 more
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4746	70518-4746-0070518-4746-0170518-4746-02
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4742	70518-4742-00
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4740	70518-4740-00
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0580	55154-0580-00
Gabapentin	Gabapentin 600 mg/1	Tablet, CoatedOral	Coupler LLC	67046-1233	67046-1233-03
Gabapentin	Gabapentin 200 mg/1	CapsuleOral	Trifluent Pharma, LLC	73352-231	73352-0231-01
Gabapentin	Gabapentin 600 mg/1	TabletOral	Coupler LLC	67046-1086	67046-1086-03

All 559 Gabapentin NDCs

Other NDCs under ANDA 204989

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

FDA NDC Directory listings under ANDA 204989
Product	Strength	Form · route	Labeler	Product NDC
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Medsource Pharmaceuticals	45865-194
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	A-S Medication Solutions	50090-7672
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	A-S Medication Solutions	50090-7673
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	A-S Medication Solutions	50090-7674
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	A-S Medication Solutions	50090-7675
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-179
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-180
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-181
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Quality Care Products, LLC	55700-949
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Quality Care Products, LLC	55700-950
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	St. Mary's Medical Park Pharmacy	60760-740
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	St. Mary's Medical Park Pharmacy	60760-741
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8484
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8485
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8486
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8487
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8488
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Coupler LLC	67046-1257
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Coupler LLC	67046-1284
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-2366

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